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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71371

382 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 02, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
The Compounding Pharmacy of America

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

382 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 382

5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

D-1431-2015
Recall number
D-1431-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
23 ML total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05012015@19, 7/30/2015

Distribution pattern

Nationwide

drug · product 2 of 382

5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

D-1432-2015
Recall number
D-1432-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
351 ML total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02232015@75, 5/24/2015; 03042015@22, 6/2/2015; 03172015@44, 6/15/2015; 03192015@21, 6/17/2015; 03232015@61, 6/21/2015; 03272015@49, 6/25/2015; 04132015@50, 7/12/2015; 04132015@54, 7/12/201; 04152015@35, 7/14/2015; 04162015@12, 7/15/2015; 04222015@39, 7/21/2015, 04242015@3, 7/23/2015; 05012015@53, 7/30/2015; 05062015@20, 8/4/2015; 05052015@105, 8/3/2015

Distribution pattern

Nationwide

drug · product 3 of 382

Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

D-1433-2015
Recall number
D-1433-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
250 ML total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05042015@40, 8/2/2015; 03202015@17, 6/18/2015; 04132015@58, 7/12/2015; 04212015@5, 7/20/2015

Distribution pattern

Nationwide

drug · product 4 of 382

Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

D-1434-2015
Recall number
D-1434-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04212015@45, 7/20/2015

Distribution pattern

Nationwide

drug · product 5 of 382

Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1435-2015
Recall number
D-1435-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
99 mL total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05042015@39, 6/8/2015; 04212015@3, 5/26/2015

Distribution pattern

Nationwide

drug · product 6 of 382

Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1436-2015
Recall number
D-1436-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
130 mL total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12052014@40, 6/3/2015; 12182014@71, 6/16/2015; 01022015@12, 7/1/2015; 02112015@56, 8/10/2015; 02132015@47, 8/12/2015; 03062015@26, 9/2/2015; 03312015@23, 9/27/2015; 04162015@2, 10/13/2015; 05012015@26, 10/28/2015; 05072015@15, 11/3/2015

Distribution pattern

Nationwide

drug · product 7 of 382

Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1437-2015
Recall number
D-1437-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
24 mL total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12012014@41, 5/30/2015

Distribution pattern

Nationwide

drug · product 8 of 382

Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1438-2015
Recall number
D-1438-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
11 mL total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12172014@7, 6/15/2015

Distribution pattern

Nationwide

drug · product 9 of 382

Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1439-2015
Recall number
D-1439-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
76 mL total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01082015@34,7/7/2015; 12162014@46, 6/14/2015; 02032015@98, 8/2/2015; 02112015@79, 8/10/2015, 02192015@15, 8/18/2015

Distribution pattern

Nationwide

drug · product 10 of 382

Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1440-2015
Recall number
D-1440-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
7 mL total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02032015@24, 8/2/2015

Distribution pattern

Nationwide

drug · product 11 of 382

L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1441-2015
Recall number
D-1441-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 mL total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03242015@36, 6/22/2015

Distribution pattern

Nationwide

drug · product 12 of 382

Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1442-2015
Recall number
D-1442-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
2923 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05052015@1, 8/3/2015; 03112015@4, 6/9/2015; 03122015@32, 6/10/2015; 03122015@90, 6/10/2015; 03232015@6, 6/21/2015; 03272015@38, 6/25/2015; 04072015@21, 7/6/2015; 05112015@75, 8/9/2015; 04222015@9, 7/21/2015

Distribution pattern

Nationwide

drug · product 13 of 382

Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1443-2015
Recall number
D-1443-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
13 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03032015@24, 6/1/2015; 03312015@79, 6/29/2015

Distribution pattern

Nationwide

drug · product 14 of 382

B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1444-2015
Recall number
D-1444-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1397 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02192015@21, 5/20/2015; 03032015@3, 6/1/2015; 02242015@37, 5/25/2015; 03122015@27, 6/10/2015; 03182015@48, 6/16/2015; 03272015@14, 6/25/2015; 04072015@16, 7/6/2015, 04072015@18, 7/6/2015, 04202015@80, 7/19/2015, 04222015@85, 7/21/2015; 05072015@25, 8/5/2015; 04272015@74, 7/26/2015; 04272015@81, 7/26/2015; 04292015@98, 7/28/2015; 05012015@17, 7/30/2015; 05042015@45, 8/2/2015; 02202015@47, 5/21/2015

Distribution pattern

Nationwide

drug · product 15 of 382

Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1445-2015
Recall number
D-1445-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04272015@23, 7/26/2015

Distribution pattern

Nationwide

drug · product 16 of 382

Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America, Knoxville, TN

D-1446-2015
Recall number
D-1446-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
66 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05042015@46, 8/2/2015

Distribution pattern

Nationwide

drug · product 17 of 382

Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1447-2015
Recall number
D-1447-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02192015@51, 5/20/2015; 04162015@14, 7/15/2015

Distribution pattern

Nationwide

drug · product 18 of 382

Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1448-2015
Recall number
D-1448-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
129 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02232015@27, 5/24/2015; 3182015@46, 6/16/2015; 04242015@45, 6/23/2015

Distribution pattern

Nationwide

drug · product 19 of 382

Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1449-2015
Recall number
D-1449-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 mL

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@3, 6/7/2015

Distribution pattern

Nationwide

drug · product 20 of 382

Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1450-2015
Recall number
D-1450-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
102 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@26, 6/18/2015; 04282015@1, 7/27/2015; 05042015@53, 8/2/2015

Distribution pattern

Nationwide

drug · product 21 of 382

Cholecalciferol 100,000 IU /ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1451-2015
Recall number
D-1451-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04272015@82, 7/26/2015

Distribution pattern

Nationwide

drug · product 22 of 382

Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN

D-1452-2015
Recall number
D-1452-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
11 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04102015@10, 7/9/2015; 04162015@41, 7/15/2015; 04092015@21, 7/8/2015

Distribution pattern

Nationwide

drug · product 23 of 382

Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN

D-1453-2015
Recall number
D-1453-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
260 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03102015@17, 6/8/2015; 03032015@14, 6/1/2015; 03272015@1, 6/25/2015; 04292015@79, 7/28/2015, 04282015@51, 7/27/2015

Distribution pattern

Nationwide

drug · product 24 of 382

Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of America, Knoxville, TN

D-1454-2015
Recall number
D-1454-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
29 mL Total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05012015@13, 5/31/2015, 05012015@16, 5/31/2015

Distribution pattern

Nationwide

drug · product 25 of 382

Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1455-2015
Recall number
D-1455-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
35 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05112015@16, 8/9/2015

Distribution pattern

Nationwide

drug · product 26 of 382

Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1456-2015
Recall number
D-1456-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
35 ML

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05042015@47, 8/2/2015

Distribution pattern

Nationwide

drug · product 27 of 382

Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1457-2015
Recall number
D-1457-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
6615 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 05062015@2, 8/4/2015; 03182015@9, 6/16/2015; 03242015@9, 6/22/2015; 03312015@72, 6/29/2015; 04152015@12, 7/14/2015; 04152015@13, 7/14/2015; 05052015@93, 8/3/2015; 05012015@35, 7/30/2015; 05072015@10, 8/5/2015

Distribution pattern

Nationwide

drug · product 28 of 382

Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1458-2015
Recall number
D-1458-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
32 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03042015@33, 8/31/2015; 03312015@29, 9/27/2015

Distribution pattern

Nationwide

drug · product 29 of 382

Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1459-2015
Recall number
D-1459-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
38 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04232015@35, 7/22/2015

Distribution pattern

Nationwide

drug · product 30 of 382

Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1460-2015
Recall number
D-1460-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05052015@24, 8/3/2015

Distribution pattern

Nationwide

drug · product 31 of 382

Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1461-2015
Recall number
D-1461-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
55 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04202015@83, 7/19/2015

Distribution pattern

Nationwide

drug · product 32 of 382

Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1462-2015
Recall number
D-1462-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
262 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@25, 6/10/2015; 03202015@31, 6/18/2015; 03172015@42, 6/15/2015; 03232015@5, 6/21/2015; 04162015@15, 7/15/2015

Distribution pattern

Nationwide

drug · product 33 of 382

DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1463-2015
Recall number
D-1463-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
30 mL total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04222015@67, 7/21/2015

Distribution pattern

Nationwide

drug · product 34 of 382

Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1464-2015
Recall number
D-1464-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
212 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12082014@56, 6/6/2015; 01222015@28, 7/21/2015; 01062015@73, 7/5/2015; 03022015@55, 8/29/2015; 03242015@94, 9/20/2015; 04222015@32, 10/19/2015; 04222015@47, 10/19/2015; 04222015@49, 10/19/2015; 04302015@54, 10/27/2015

Distribution pattern

Nationwide

drug · product 35 of 382

Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1465-2015
Recall number
D-1465-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
98 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01122015@36, 7/11/2015; 04022015@40, 9/29/2015; 05072015@56, 11/3/2015

Distribution pattern

Nationwide

drug · product 36 of 382

Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1466-2015
Recall number
D-1466-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
144 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01082015@8, 7/7/2015; 12052014@62, 6/3/2015; 02242015@10, 8/23/2015; 02122015@29, 7/1/2015; 03032015@19, 8/30/2015; 04232015@13, 10/20/2015

Distribution pattern

Nationwide

drug · product 37 of 382

Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1467-2015
Recall number
D-1467-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
120 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 11262014@20, 5/25/2015; 01152015@27, 7/14/2015; 02232015@21, 8/22/2015; 02242015@23, 8/23/2015; 05052015@68, 11/1/2015

Distribution pattern

Nationwide

drug · product 38 of 382

Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1468-2015
Recall number
D-1468-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
120 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12112014@4, 6/9/2015; 02102015@18, 8/9/2015; 03022015@59, 8/29/2015; 03242015@96, 9/20/2015; 04292015@16, 10/26/2015

Distribution pattern

Nationwide

drug · product 39 of 382

Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1469-2015
Recall number
D-1469-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
120 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12082014@58, 6/6/2015; 02032015@42, 7/1/2015; 02272015@28, 8/26/2015; 03242015@97, 9/20/2015; 05052015@62, 11/1/2015

Distribution pattern

Nationwide

drug · product 40 of 382

Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

D-1470-2015
Recall number
D-1470-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
48 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02242015@1, 8/23/2015; 05042015@29, 10/31/2015

Distribution pattern

Nationwide

drug · product 41 of 382

Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

D-1471-2015
Recall number
D-1471-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
144 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12012014@59, 5/30/2015; 01122015@34, 7/11/2015; 02102015@42, 7/1/2015; 03162015@12, 9/12/2015; 04282015@59, 10/25/2015; 05052015@65, 11/1/2015

Distribution pattern

Nationwide

drug · product 42 of 382

Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

D-1472-2015
Recall number
D-1472-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
10 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03112015@11, 9/7/2015

Distribution pattern

Nationwide

drug · product 43 of 382

Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

D-1473-2015
Recall number
D-1473-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
24 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12182014@21, 6/16/2015

Distribution pattern

Nationwide

drug · product 44 of 382

Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

D-1474-2015
Recall number
D-1474-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
96 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 11212014@11, 5/20/2015; 02092015@42, 8/8/2015; 02252015@76, 7/1/2015; 04072015@35, 10/4/2015

Distribution pattern

Nationwide

drug · product 45 of 382

Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

D-1475-2015
Recall number
D-1475-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
144 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 11212014@13, 5/20/2015; 12182014@35, 6/16/2015; 02202015@1, 8/19/2015; 03022015@48, 8/29/2015; 03172015@33, 9/13/2015; 04232015@24, 10/20/2015

Distribution pattern

Nationwide

drug · product 46 of 382

Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

D-1476-2015
Recall number
D-1476-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
24 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03182015@14, 9/14/2015

Distribution pattern

Nationwide

drug · product 47 of 382

Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1477-2015
Recall number
D-1477-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
32 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@48, 9/8/2015; 04212015@20, 10/18/2015; 05052015@37, 11/1/2015

Distribution pattern

Nationwide

drug · product 48 of 382

Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1478-2015
Recall number
D-1478-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 11262014@56, 5/25/2015; 01262015@16, 7/25/2015; 01302015@51, 7/29/2015; 03272015@41, 9/23/2015

Distribution pattern

Nationwide

drug · product 49 of 382

Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1479-2015
Recall number
D-1479-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
36 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04302015@35, 10/27/2015

Distribution pattern

Nationwide

drug · product 50 of 382

Fentanyl 10,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1480-2015
Recall number
D-1480-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04062015@14, 7/5/2015; 05012015@48, 7/30/2015

Distribution pattern

Nationwide

drug · product 51 of 382

Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

D-1481-2015
Recall number
D-1481-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@27, 5/20/2015

Distribution pattern

Nationwide

drug · product 52 of 382

Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1482-2015
Recall number
D-1482-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@16, 6/7/2015

Distribution pattern

Nationwide

drug · product 53 of 382

Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN

D-1483-2015
Recall number
D-1483-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
66 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04062015@12, 7/5/2015; 04062015@35, 7/5/2015; 05012015@50, 7/30/2015

Distribution pattern

Nationwide

drug · product 54 of 382

Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1484-2015
Recall number
D-1484-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03232015@10, 6/21/2015

Distribution pattern

Nationwide

drug · product 55 of 382

Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1485-2015
Recall number
D-1485-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@85, 5/31/2015; 03202015@76, 6/18/2015

Distribution pattern

Nationwide

drug · product 56 of 382

Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1486-2015
Recall number
D-1486-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
65 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@51, 5/20/2015; 04222015@22, 7/21/2015

Distribution pattern

Nationwide

drug · product 57 of 382

Fentanyl 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1487-2015
Recall number
D-1487-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@70, 6/18/2015; 03242015@103, 6/22/2015

Distribution pattern

Nationwide

drug · product 58 of 382

Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

D-1488-2015
Recall number
D-1488-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
129 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@14, 5/26/2015; 04012015@2, 6/30/2015; 04272015@30, 7/26/2015

Distribution pattern

Nationwide

drug · product 59 of 382

Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

D-1489-2015
Recall number
D-1489-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@2, 5/31/2015

Distribution pattern

Nationwide

drug · product 60 of 382

Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1490-2015
Recall number
D-1490-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@71, 5/20/2015; 04272015@31, 7/26/2015

Distribution pattern

Nationwide

drug · product 61 of 382

Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1491-2015
Recall number
D-1491-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
67 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@3, 5/31/2015; 03202015@54, 6/18/2015; 04172015@34, 6/16/2015

Distribution pattern

Nationwide

drug · product 62 of 382

Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1492-2015
Recall number
D-1492-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@1, 6/14/2015

Distribution pattern

Nationwide

drug · product 63 of 382

Fentanyl 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1493-2015
Recall number
D-1493-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@30, 6/7/2015

Distribution pattern

Nationwide

drug · product 64 of 382

Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1494-2015
Recall number
D-1494-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@2, 6/10/2015

Distribution pattern

Nationwide

drug · product 65 of 382

Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1495-2015
Recall number
D-1495-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@29, 6/7/2015

Distribution pattern

Nationwide

drug · product 66 of 382

Fentanyl 5,000 mcg/ml + Baclofen 250 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1496-2015
Recall number
D-1496-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04032015@30, 7/2/2015

Distribution pattern

Nationwide

drug · product 67 of 382

Fentanyl 5,000 mcg/ml, + Bupivacaine 15 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1497-2015
Recall number
D-1497-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@73, 6/18/2015

Distribution pattern

Nationwide

drug · product 68 of 382

Fentanyl 5,000 mcg/ml + Clonidine 3,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1498-2015
Recall number
D-1498-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
23 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04172015@36m, 6/16/2015

Distribution pattern

Nationwide

drug · product 69 of 382

Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1499-2015
Recall number
D-1499-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
23 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04172015@24, 6/16/2015

Distribution pattern

Nationwide

drug · product 70 of 382

Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1500-2015
Recall number
D-1500-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
66 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@13, 6/7/2015; 04032015@25, 7/2/2015; 05012015@47, 7/30/2015

Distribution pattern

Nationwide

drug · product 71 of 382

Fentanyl 8,000 mcg/ml, + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1501-2015
Recall number
D-1501-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03242015@103, 6/22/2015

Distribution pattern

Nationwide

drug · product 72 of 382

Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1502-2015
Recall number
D-1502-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04222015@69, 7/21/2015

Distribution pattern

Nationwide

drug · product 73 of 382

Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1503-2015
Recall number
D-1503-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
559 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@78, 6/14/2015; 03262015@42, 6/24/2015; 04202015@82, 7/19/2015; 04222015@79, 7/21/2015; 05042015@49, 8/2/2015; 04222015@57, 7/21/2015; 04272015@19, 7/26/2015

Distribution pattern

Nationwide

drug · product 74 of 382

HCG 1,000 IU/ml + Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1504-2015
Recall number
D-1504-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
25 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05062015@48, 7/5/2015; 03232015@78, 5/22/2015

Distribution pattern

Nationwide

drug · product 75 of 382

HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1505-2015
Recall number
D-1505-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
3120 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04152015@15, 6/14/2015; 03232015@64, 5/22/2015; 04222015@68, 6/21/2015; 04272015@86, 6/26/2015; 04292015@62, 6/28/2015; 05062015@5, 7/5/2015

Distribution pattern

Nationwide

drug · product 76 of 382

HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1506-2015
Recall number
D-1506-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
398 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04172015@3, 6/16/2015; 03242015@49, 5/23/2015; 03272015@31, 5/26/2015; 05052015@51, 7/4/2015; 03252015@2, 5/24/2015; 03252015@30, 5/24/2015; 03302015@45, 5/29/2015; 04162015@26, 6/15/2015; 04212015@7, 6/20/2015; 04172015@71, 6/16/2015; 04292015@53, 6/28/2015; 04072015@53, 6/6/2015; 04272015@44, 6/26/2015

Distribution pattern

Nationwide

drug · product 77 of 382

HCG 1,000 IU/ml + Methylcobalamin 1 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1507-2015
Recall number
D-1507-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
48 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03312015@25, 5/30/2015; 03312015@45, 5/30/2015; 03312015@50, 5/30/2015; 04292015@58, 6/28/2015

Distribution pattern

Nationwide

drug · product 78 of 382

HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1508-2015
Recall number
D-1508-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05052015@55, 8/3/2015

Distribution pattern

Nationwide

drug · product 79 of 382

HCG 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1509-2015
Recall number
D-1509-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
161 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03242015@21, 5/23/2015; 04132015@32, 6/12/2015; 04172015@45, 6/16/2015; 05052015@40, 7/4/2015

Distribution pattern

Nationwide

drug · product 80 of 382

HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 15 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

D-1510-2015
Recall number
D-1510-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
57 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04152015@18, 6/14/2015; 04222015@25, 6/21/2015; 04292015@75, 6/28/2015; 05012015@41, 6/30/2015; 05042015@71, 7/3/2015; 05082015@61, 7/7/2015

Distribution pattern

Nationwide

drug · product 81 of 382

HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1511-2015
Recall number
D-1511-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
61 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03242015@5, 5/23/2015; 05042015@78, 7/3/2015; 03262015@2, 5/25/2015; 04062015@52, 6/5/2015; 04242015@58, 6/23/2015; 05072015@17, 7/6/2015; 05082015@19, 7/7/2015

Distribution pattern

Nationwide

drug · product 82 of 382

HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

D-1512-2015
Recall number
D-1512-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
4 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04232015@36, 6/22/2015

Distribution pattern

Nationwide

drug · product 83 of 382

HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

D-1513-2015
Recall number
D-1513-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
39 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03272015@34, 5/26/2015; 05042015@32, 7/3/2015; 04102015@59, 6/9/2015

Distribution pattern

Nationwide

drug · product 84 of 382

HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 40 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

D-1514-2015
Recall number
D-1514-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
56 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04202015@19, 6/19/2015; 03272015@35, 5/26/2015; 05042015@59, 7/3/2015

Distribution pattern

Nationwide

drug · product 85 of 382

HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 42 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

D-1515-2015
Recall number
D-1515-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
10 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05082015@49, 7/7/2015

Distribution pattern

Nationwide

drug · product 86 of 382

HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1516-2015
Recall number
D-1516-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
5 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03242015@47, 5/23/2015

Distribution pattern

Nationwide

drug · product 87 of 382

HCG 5,000 IU/ml + Methylcobalamin 500 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1517-2015
Recall number
D-1517-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04032015@53, 6/2/2015

Distribution pattern

Nationwide

drug · product 88 of 382

HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1518-2015
Recall number
D-1518-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
695 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04092015@6,6/8/2015; 04202015@38, 6/19/2015; 04202015@8, 6/19/2015; 03202015@99, 5/22/2015; 03302015@54, 5/29/2015; 03312015@56, 5/30/2015; 04072015@7, 6/6/2015; 04062015@56, 6/5/2015; 04142015@86, 6/13/2015; 05052015@49, 7/4/2015; 05062015@30, 7/5/2015

Distribution pattern

Nationwide

drug · product 89 of 382

HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1519-2015
Recall number
D-1519-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1558 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05062015@32, 8/4/2015; 02272015@16, 5/28/2015; 03032015@33, 6/1/2015; 03042015@36, 6/2/2015; 03062015@43, 6/4/2015; 03092015@77, 6/7/2015; 03092015@92, 6/7/2015; 03132015@17, 11/2015; 03162015@23, 14/2015; 03172015@40, 5/2015; 03232015@39, 6/21/2015; 03242015@23, 6/22/2015; 03242015@29, 6/22/2015; 04162015@46, 7/15/2015; 04012015@8, 6/30/2015; 04062015@10, 7/5/2015; 04072015@17, 7/6/2015; 04142015@2, 7/13/2015; 04132015@34, 7/12/2015; 04202015@45, 7/19/2015; 04172015@63, 7/16/2015; 04272015@5, 7/26/2015; 05082015@44, 8/6/2015

Distribution pattern

Nationwide

drug · product 90 of 382

HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1520-2015
Recall number
D-1520-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
58 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03252015@5; 5/24/2015; 03232015@34, 5/22/2015; 04152015@40, 6/14/2015; 04072015@46, 6/6/2015; 04222015@16, 6/21/2015; 04302015@46, 6/29/2015

Distribution pattern

Nationwide

drug · product 91 of 382

HCG 2,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1521-2015
Recall number
D-1521-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
51 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04292015@41, 6/28/2015; 05052015@80, 7/4/2015; 05062015@51, 7/5/2015

Distribution pattern

Nationwide

drug · product 92 of 382

HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1522-2015
Recall number
D-1522-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1043 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05072015@2, 7/6/2015; 04082015@25, 6/7/2015; 03042015@54, 6/2/2015; 04142015@16, 6/13/2015; 03312015@37, 5/30/2015; 04062015@75, 6/5/2015; 05112015@15, 7/10/2015; 04272015@21, 6/26/2015; 04272015@62, 6/26/2015

Distribution pattern

Nationwide

drug · product 93 of 382

HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1523-2015
Recall number
D-1523-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
55 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04162015@25, 6/15/2015

Distribution pattern

Nationwide

drug · product 94 of 382

HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1524-2015
Recall number
D-1524-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
112 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04172015@59, 6/16/2015; 04302015@57, 6/29/2015; 03262015@39, 5/25/2015; 04012015@42, 5/31/2015; 04022015@18, 6/1/2015; 04302015@4, 6/29/2015

Distribution pattern

Nationwide

drug · product 95 of 382

HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1525-2015
Recall number
D-1525-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
60 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03302015@35, 5/29/2015; 04172015@15, 6/16/2015

Distribution pattern

Nationwide

drug · product 96 of 382

HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1526-2015
Recall number
D-1526-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
40 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04012015@78, 5/31/2015; 04222015@61, 6/21/2015; 04302015@55, 6/29/2015

Distribution pattern

Nationwide

drug · product 97 of 382

HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 30 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

D-1527-2015
Recall number
D-1527-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
89 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04132015@52, 6/12/2015; 04232015@26, 6/22/2015

Distribution pattern

Nationwide

drug · product 98 of 382

HCG 2,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1528-2015
Recall number
D-1528-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
99 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03312015@18, 5/30/2015; 03252015@49, 5/24/2015; 04012015@60 5/31/2015; 05112015@59, 7/10/2015; 04062015@39, 6/5/2015; 04072015@25, 6/6/2015; 04072015@74, 6/6/2015; 04142015@44, 6/13/2015; 04172015@72, 6/16/2015; 04172015@77, 6/16/2015; 04232015@8, 6/22/2015; 04222015@60, 6/21/2015; 04242015@11, 6/23/2015; 04292015@33, 6/28/2015

Distribution pattern

Nationwide

drug · product 99 of 382

HCG 3,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1529-2015
Recall number
D-1529-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
45 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04062015@2, 6/5/2015; 04212015@76, 6/20/2015; 04272015@33, 6/26/2015

Distribution pattern

Nationwide

drug · product 100 of 382

HCG 4,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1530-2015
Recall number
D-1530-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
53 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03262015@37, 5/25/2015; 04032015@4, 6/2/2015; 4292015@56, 6/28/2015

Distribution pattern

Nationwide

drug · product 101 of 382

HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1531-2015
Recall number
D-1531-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
60 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03272015@23, 5/26/2015; 03312015@20, 5/30/2015; 04062015@4, 6/5/2015; 05112015@23, 7/10/2015

Distribution pattern

Nationwide

drug · product 102 of 382

HCG 1,200 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1532-2015
Recall number
D-1532-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
28 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03272015@22, 5/26/2015; 04062015@19, 6/5/2015; 04212015@39, 6/20/2015; 04222015@62, 6/21/2015

Distribution pattern

Nationwide

drug · product 103 of 382

HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

D-1533-2015
Recall number
D-1533-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
200 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04092015@59, 6/8/2015; 04162015@28, 6/15/2015; 03272015@2, 5/26/2015; 03302015@34, 5/29/2015; 04062015@71, 6/5/2015; 04162015@54, 6/15/2015; 05012015@36, 6/30/2015; 05112015@5, 7/10/2015

Distribution pattern

Nationwide

drug · product 104 of 382

Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1534-2015
Recall number
D-1534-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
20 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03042015@6, 6/2/2015; 03122015@80, 6/10/2015; 03262015@43, 6/24/2015

Distribution pattern

Nationwide

drug · product 105 of 382

Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1535-2015
Recall number
D-1535-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03232015@42, 6/21/2015; 03252015@25, 6/23/2015

Distribution pattern

Nationwide

drug · product 106 of 382

Hyaluronic Acid Sodium 35 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1536-2015
Recall number
D-1536-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04062015@66, 7/5/2015; 04072015@57, 7/6/2015

Distribution pattern

Nationwide

drug · product 107 of 382

Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1537-2015
Recall number
D-1537-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
5 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02202015@6, 5/21/2015

Distribution pattern

Nationwide

drug · product 108 of 382

Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1538-2015
Recall number
D-1538-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
50 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04132015@19, 7/12/2015; 02202015@12, 5/21/2015; 05112015@17, 8/9/2015

Distribution pattern

Nationwide

drug · product 109 of 382

Hyaluronidase 175 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1539-2015
Recall number
D-1539-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
18 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03112015@15, 6/9/2015

Distribution pattern

Nationwide

drug · product 110 of 382

Hydromorphone 0.25 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1540-2015
Recall number
D-1540-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
86 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04092015@64, 7/8/2015; 04032015@28, 7/2/2015

Distribution pattern

Nationwide

drug · product 111 of 382

Hydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1541-2015
Recall number
D-1541-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04272015@22, 7/26/2015

Distribution pattern

Nationwide

drug · product 112 of 382

Hydromorphone 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1542-2015
Recall number
D-1542-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
190 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04212015@19, 7/20/2015; 02232015@28, 5/24/2015; 02252015@18, 5/26/2015; 03022015@12, 5/31/2015; 03302015@61, 6/28/2015; 04222015@11, 7/21/2015

Distribution pattern

Nationwide

drug · product 113 of 382

Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1543-2015
Recall number
D-1543-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
23 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04142015@74, 7/13/2015

Distribution pattern

Nationwide

drug · product 114 of 382

Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1544-2015
Recall number
D-1544-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02202015@5, 5/21/2015

Distribution pattern

Nationwide

drug · product 115 of 382

Hydromorphone 12.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1545-2015
Recall number
D-1545-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
86 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@50, 6/14/2015; 04142015@81, 7/13/2015

Distribution pattern

Nationwide

drug · product 116 of 382

Hydromorphone 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1546-2015
Recall number
D-1546-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@67, 6/18/2015

Distribution pattern

Nationwide

drug · product 117 of 382

Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1547-2015
Recall number
D-1547-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
130 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@26, 6/7/2015; 03122015@95, 6/10/2015; 04132015@5, 6/12/2015; 04292015@8, 6/28/2015

Distribution pattern

Nationwide

drug · product 118 of 382

Hydromorphone 20 mg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1548-2015
Recall number
D-1548-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
40 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@86, 6/14/2015; 04142015@57, 7/13/2015

Distribution pattern

Nationwide

drug · product 119 of 382

Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1549-2015
Recall number
D-1549-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@93, 6/10/2015; 04242015@46, 7/23/2015

Distribution pattern

Nationwide

drug · product 120 of 382

Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1550-2015
Recall number
D-1550-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
45 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@64, 6/14/2015; 04162015@53, 7/15/2015

Distribution pattern

Nationwide

drug · product 121 of 382

Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1551-2015
Recall number
D-1551-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@79, 6/18/2015

Distribution pattern

Nationwide

drug · product 122 of 382

Hydromorphone 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1552-2015
Recall number
D-1552-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
87 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@10, 5/31/2015; 04132015@4, 6/12/2015; 04222015@1, 6/21/2015

Distribution pattern

Nationwide

drug · product 123 of 382

Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1553-2015
Recall number
D-1553-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@59, 5/26/2015; 03202015@55, 6/18/2015

Distribution pattern

Nationwide

drug · product 124 of 382

Hydromorphone 65 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1554-2015
Recall number
D-1554-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@5, 6/14/2015

Distribution pattern

Nationwide

drug · product 125 of 382

Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1555-2015
Recall number
D-1555-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@85, 6/18/2015

Distribution pattern

Nationwide

drug · product 126 of 382

Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1556-2015
Recall number
D-1556-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1098 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@27, 6/18/2015; 04152015@1, 7/14/2015; 04222015@66, 7/21/2015; 05052015@5, 8/3/2015

Distribution pattern

Nationwide

drug · product 127 of 382

Hydroxocobalamin 10,000 mcg/ml Injection, Multi-Dose Vial, sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1557-2015
Recall number
D-1557-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
63 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04212015@52, 7/20/2015

Distribution pattern

Nationwide

drug · product 128 of 382

Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1558-2015
Recall number
D-1558-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
353 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03032015@4, 6/1/2015; 03312015@71, 6/29/2015

Distribution pattern

Nationwide

drug · product 129 of 382

Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1559-2015
Recall number
D-1559-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
165 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@28, 6/18/2015; 05042015@42, 8/2/2015

Distribution pattern

Nationwide

drug · product 130 of 382

Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1560-2015
Recall number
D-1560-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
37 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04162015@27, 10/13/2015; 04032015@20, 9/30/2015; 04202015@47, 10/17/2015

Distribution pattern

Nationwide

drug · product 131 of 382

L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1561-2015
Recall number
D-1561-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
63 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05042015@50, 6/8/2015

Distribution pattern

Nationwide

drug · product 132 of 382

Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN

D-1562-2015
Recall number
D-1562-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
160 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04062015@78, 7/5/2015

Distribution pattern

Nationwide

drug · product 133 of 382

Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1563-2015
Recall number
D-1563-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
45 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05122015@20, 5/26/2015

Distribution pattern

Nationwide

drug · product 134 of 382

Magnesium Chloride 200 mg/ml (20%) Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1564-2015
Recall number
D-1564-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
924 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04202015@79, 7/19/2015; 04072015@24, 7/6/2015; 04222015@10, 7/21/2015; 05052015@4, 8/3/2015

Distribution pattern

Nationwide

drug · product 135 of 382

Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1565-2015
Recall number
D-1565-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
376 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@31, 6/10/2015; 03202015@23, 6/18/2015; 05042015@79, 8/2/2015, 04272015@75, 7/26/2015; 04292015@61, 7/28/2015

Distribution pattern

Nationwide

drug · product 136 of 382

Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1566-2015
Recall number
D-1566-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
425 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04072015@30, 7/6/2015; 05042015@23, 8/2/2015

Distribution pattern

Nationwide

drug · product 137 of 382

Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1567-2015
Recall number
D-1567-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
2442 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04222015@75, 7/21/2015

Distribution pattern

Nationwide

drug · product 138 of 382

Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1568-2015
Recall number
D-1568-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
63 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04212015@8, 7/20/2015; 03032015@11, 6/1/2015; 03102015@49, 6/8/2015; 03192015@9, 6/17/2015; 05042015@14, 8/2/2015; 04072015@20, 7/6/2015; 05042015@51, 8/2/2015

Distribution pattern

Nationwide

drug · product 139 of 382

Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1569-2015
Recall number
D-1569-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1588 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@86, 5/31/2015; 04012015@71, 6/30/2015; 02202015@43, 5/21/2015,; 2232015@74, 5/24/2015; 02272015@70, 5/28/2015; 03052015@8, 6/3/2015; 03102015@61, 6/8/2015; 03092015@97, 6/7/2015; 03202015@98, 6/18/2015; 03232015@62, 6/21/2015; 03272015@50, 6/25/2015; 03312015@47, 6/29/2015; 04022015@20, 7/1/2015; 04062015@1, 7/5/2015; 04062015@61, 7/5/2015; 04132015@49, 7/12/2015; 04132015@53, 7/12/2015; 04152015@26, 7/14/2015; 04162015@20, 7/15/2015; 04222015@41, 7/21/2015; 04162015@50, 7/15/2015; 05012015@52, 7/30/2015; 04242015@64, 7/1/2015; 04302015@3, 7/29/2015; 04302015@40, 7/29/2015; 04302015@43, 7/29/2015; 04292015@99, 7/28/2015; 05062015@19, 8/4/2015; 05122015@14, 7/11/2015

Distribution pattern

Nationwide

drug · product 140 of 382

Methylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1570-2015
Recall number
D-1570-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
255 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03052015@5, 6/3/2015; 03162015@63, 6/14/2015; 04222015@70, 7/21/2015

Distribution pattern

Nationwide

drug · product 141 of 382

Methylcobalamin 4,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1571-2015
Recall number
D-1571-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
79 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03062015@27, 6/4/2015; 03182015@45, 6/16/2015

Distribution pattern

Nationwide

drug · product 142 of 382

Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1572-2015
Recall number
D-1572-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03042015@15, 6/2/2015

Distribution pattern

Nationwide

drug · product 143 of 382

Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1573-2015
Recall number
D-1573-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
99 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02192015@39, 5/20/2015; 03172015@46, 6/15/2015; 04162015@43, 7/15/2015

Distribution pattern

Nationwide

drug · product 144 of 382

Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Sterile-Multi-Dose Vial,Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1574-2015
Recall number
D-1574-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
78 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04212015@36, 7/20/2015; 03202015@56, 6/18/2015; 03182015@10, 6/16/2015

Distribution pattern

Nationwide

drug · product 145 of 382

Methylcobalamin 1,000 mcg/ml + Hydroxocobalamin 1,000 mcg/ml Injectable, Preservative Free, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1575-2015
Recall number
D-1575-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
32 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04202015@81, 7/19/2015

Distribution pattern

Nationwide

drug · product 146 of 382

Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1576-2015
Recall number
D-1576-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
188 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02272015@17, 5/28/2015; 04082015@47, 7/7/2015

Distribution pattern

Nationwide

drug · product 147 of 382

MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1577-2015
Recall number
D-1577-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1076 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03172015@50, 6/15/2015; 04142015@11, 7/13/2015; 03232015@32, 6/21/2015; 03232015@37, 6/21/2015; 03302015@53, 6/28/2015; 04142015@10, 7/13/2015; 04302015@47, 7/29/2015; 04292015@84, 7/28/2015; 05042015@55, 8/2/2015

Distribution pattern

Nationwide

drug · product 148 of 382

MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1578-2015
Recall number
D-1578-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
155 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02242015@38, 5/25/2015; 05082015@25, 8/6/2015

Distribution pattern

Nationwide

drug · product 149 of 382

MIC-B12+B6 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1579-2015
Recall number
D-1579-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
473 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02232015@93, 5/24/2015; 03132015@21, 6/11/2015, 04062015@38, 7/5/2015; 04082015@17, 7/7/2015; 04272015@83, 7/26/2015

Distribution pattern

Nationwide

drug · product 150 of 382

MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1580-2015
Recall number
D-1580-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
806 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@29, 5/26/2015; 03112015@36, 6/9/2015; 03192015@18, 6/17/2015; 04162015@40, 7/15/2015

Distribution pattern

Nationwide

drug · product 151 of 382

Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1581-2015
Recall number
D-1581-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
78 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 06132014@45, 6/13/2015; 02032015@82, 2/3/2016; 03242015@26, 3/23/2016; 08142014@46, 8/14/2015; 07172014@54, 7/17/2015; 12032014@77, 12/3/2015; 03102015@23, 3/9/2016; 03042015@44, 3/3/2016

Distribution pattern

Nationwide

drug · product 152 of 382

Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1582-2015
Recall number
D-1582-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05112015@22, 5/10/2016; 10202014@63, 10/20/2015; 10272014@17, 10/27/2015; 11102014@20, 11/10/2015; 12302014@8, 12/30/2015; 08252014@26, 8/25/2015; 08262014@20, 8/26/2015; 09052014@13, 9/5/2015; 01262015@15, 1/26/2016; 01022015@22, 1/2/2016; 02232015@50, 2/23/2016; 04132015@59, 4/12/2016; 04222015@40, 4/21/2016; 05062015@21, 5/5/2016; 06042014@17, 6/4/2015

Distribution pattern

Nationwide

drug · product 153 of 382

Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1583-2015
Recall number
D-1583-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
2255 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 10222014@55, 10/22/2015; 10032014@43, 10/3/2015; 12012014@42, 12/1/2015; 01092015@35, 1/9/2016; 02022015@52, 2/2/2016; 02232015@78, 2/23/2016; 03122015@81, 3/11/2016; 03312015@38, 3/30/2016

Distribution pattern

Nationwide

drug · product 154 of 382

Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America, Knoxville, TN

D-1584-2015
Recall number
D-1584-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
315 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03102015@55, 3/9/2016; 03172015@62, 3/16/2016; 04102015@7, 4/9/2016

Distribution pattern

Nationwide

drug · product 155 of 382

Morphine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1585-2015
Recall number
D-1585-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
429 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@1, 5/26/2015; 03062015@38, 6/4/2015; 03162015@77, 6/14/2015; 03242015@44, 6/22/2015; 03242015@51, 6/22/2015; 04072015@58, 7/6/2015; 04132015@6, 6/12/2015; 04142015@60, 6/13/2015; 04222015@12, 6/21/2015; 05122015@16, 7/11/2015

Distribution pattern

Nationwide

drug · product 156 of 382

Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

D-1586-2015
Recall number
D-1586-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
151 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@13, 5/31/2015; 03162015@51, 6/14/2015; 04072015@59, 7/6/2015; 04272015@26, 7/26/2015

Distribution pattern

Nationwide

drug · product 157 of 382

Morphine 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1587-2015
Recall number
D-1587-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
86 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@54, 6/14/2015; 04222015@14, 7/21/2015

Distribution pattern

Nationwide

drug · product 158 of 382

Morphine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1588-2015
Recall number
D-1588-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
235 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@98, 6/10/2015; 03162015@57, 6/14/2015; 03162015@79, 6/14/2015; 04062015@42, 7/5/2015; 05042015@4, 7/2/2015; 05042015@69, 7/3/2015; 05122015@17, 7/11/2015

Distribution pattern

Nationwide

drug · product 159 of 382

Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1589-2015
Recall number
D-1589-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@81, 5/31/2015

Distribution pattern

Nationwide

drug · product 160 of 382

Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1590-2015
Recall number
D-1590-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
66 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@11, 6/7/2015; 03302015@7, 6/28/2015; 4242015@50, 7/23/2015

Distribution pattern

Nationwide

drug · product 161 of 382

Morphine 25 mg/ml + Baclofen 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1591-2015
Recall number
D-1591-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
86 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@22, 5/31/2015; 04072015@66, 7/6/2015

Distribution pattern

Nationwide

drug · product 162 of 382

Morphine 25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1592-2015
Recall number
D-1592-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
458 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@2, 5/26/2015; 03022015@14, 5/31/2015; 03242015@63, 6/22/2015; 04072015@62, 7/6/2015; 04222015@15, 7/21/2015

Distribution pattern

Nationwide

drug · product 163 of 382

Morphine 30 mg/ml + Baclofen 10 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1593-2015
Recall number
D-1593-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03242015@74, 6/22/2015

Distribution pattern

Nationwide

drug · product 164 of 382

Morphine 30 mg/ml + Bupivacaine 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1594-2015
Recall number
D-1594-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
129 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@10, 5/26/2015; 03242015@75, 6/22/2015; 04222015@20, 7/21/2015

Distribution pattern

Nationwide

drug · product 165 of 382

Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1595-2015
Recall number
D-1595-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
87 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@20, 6/7/2015; 03202015@72, 6/18/2015; 04132015@9, 6/12/2015

Distribution pattern

Nationwide

drug · product 166 of 382

Morphine 33 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1596-2015
Recall number
D-1596-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03242015@68, 6/22/2015

Distribution pattern

Nationwide

drug · product 167 of 382

Morphine 35 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1597-2015
Recall number
D-1597-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
296 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04142015@64, 7/13/2015; 02252015@4, 5/26/2015; 03162015@59, 6/14/2015; 03242015@71, 6/22/2015; 04222015@17, 6/21/2015

Distribution pattern

Nationwide

drug · product 168 of 382

Morphine 36 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile- Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1598-2015
Recall number
D-1598-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@83, 5/31/2015

Distribution pattern

Nationwide

drug · product 169 of 382

Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1599-2015
Recall number
D-1599-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
103 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@5, 5/26/2015; 03022015@19, 5/31/2015; 04062015@48, 7/5/2015; 04212015@23, 7/20/2015

Distribution pattern

Nationwide

drug · product 170 of 382

Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1600-2015
Recall number
D-1600-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@7, 6/14/2015

Distribution pattern

Nationwide

drug · product 171 of 382

Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1601-2015
Recall number
D-1601-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@6, 6/14/2015

Distribution pattern

Nationwide

drug · product 172 of 382

Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1602-2015
Recall number
D-1602-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
45 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05042015@3, 8/2/2015; 03122015@101, 5/20/2015

Distribution pattern

Nationwide

drug · product 173 of 382

Morphine 40 mg/ml + Fentanyl 2,000 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1603-2015
Recall number
D-1603-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
86 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04142015@73, 7/13/2015; 03162015@65, 6/14/2015

Distribution pattern

Nationwide

drug · product 174 of 382

Morphine 42 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1604-2015
Recall number
D-1604-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@4, 6/10/2015; 05012015@22, 7/30/2015

Distribution pattern

Nationwide

drug · product 175 of 382

Morphine 45 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1605-2015
Recall number
D-1605-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03232015@6/21/2015

Distribution pattern

Nationwide

drug · product 176 of 382

Morphine 45 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1606-2015
Recall number
D-1606-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
23 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04142015@80; 7/13/2015

Distribution pattern

Nationwide

drug · product 177 of 382

Morphine 50 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1607-2015
Recall number
D-1607-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
944 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04142015@54, 6/13/2015; 04092015@68, 6/8/2015; 02252015@6, 5/26/2015; 05042015@68, 7/3/2015; 03022015@20, 05/31/2015; 031192015@5, 6/9/2015; 03092015@22, 6/7/2015; 03122015@3, 6/10/2015; 03162015@81, 6/14/2015; 03242015@74, 6/22/2015, 03302015@64, 6/28/2015; 04062015@46, 7/5/2015; 04212015@25, 6/20/2015; 04222015@18, 6/21/2015, 04242015@56, 6/23/2015; 04272015@29, 6/26/2015; 05012015@18, 6/30/2015; 05082015@32, 7/7/2015

Distribution pattern

Nationwide

drug · product 178 of 382

Morphine 50 mg/ml + Bupivacaine 2.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1608-2015
Recall number
D-1608-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04142015@77, 6/13/2015

Distribution pattern

Nationwide

drug · product 179 of 382

Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1609-2015
Recall number
D-1609-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
86 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02272015@33, 5/28/2015; 04012015@3, 6/30/2015

Distribution pattern

Nationwide

drug · product 180 of 382

Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1610-2015
Recall number
D-1610-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
129 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03222015@23, 5/31/2015; 04072015@68, 7/6/2015; 04142015@76, 7/13/2015

Distribution pattern

Nationwide

drug · product 181 of 382

Morphine 50 mg/ml +Fentanyl 1,000 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1611-2015
Recall number
D-1611-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
133 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@4, 5/31/2015; 03092015@12, 6/7/2015; 03302015@5, 6/28/2015; 04172015@44, 6/16/2015; 04032015@29, 7/202015; 04242015@57, 6/23/2015

Distribution pattern

Nationwide

drug · product 182 of 382

Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1612-2015
Recall number
D-1612-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02232015@19, 5/24/2015

Distribution pattern

Nationwide

drug · product 183 of 382

Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1613-2015
Recall number
D-1613-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04012015@4, 6/30/2015

Distribution pattern

Nationwide

drug · product 184 of 382

Morphine 70 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1614-2015
Recall number
D-1614-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 03222015@80, 5/31/2015; 03202015@77, 6/18/2015

Distribution pattern

Nationwide

drug · product 185 of 382

Morphine 70 mg/ml + Clonidine 1,100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1615-2015
Recall number
D-1615-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02232015@22, 5/24/2015; 03202015@81, 6/18/2015

Distribution pattern

Nationwide

drug · product 186 of 382

Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1616-2015
Recall number
D-1616-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
169 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015: 02272015@1, 8/26/2015; 12182015@67, 6/16/2015; 02062015@141, 8/5/2015; 04222015@13, 9/29/2015; 04072015@33, 10/4/2015; 04212015@13, 10/18/2015; 04082015@7, 10/5/2015 ; 04142015@24, 10/11/2015; 04272015@84, 10/24/2015; and 05082015@7, 11/4/2015

Distribution pattern

Nationwide

drug · product 187 of 382

Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1617-2015
Recall number
D-1617-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
24 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@49, 9/5/2015

Distribution pattern

Nationwide

drug · product 188 of 382

Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1618-2015
Recall number
D-1618-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
200 gm

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 01282015@15 and 03182015@54

Distribution pattern

Nationwide

drug · product 189 of 382

Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1619-2015
Recall number
D-1619-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
90 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 03102015@4 6/8/2015 03052015@29 6/3/2015 04272015@37 7/26/2015 05042015@17 8/2/2015

Distribution pattern

Nationwide

drug · product 190 of 382

PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1620-2015
Recall number
D-1620-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
188 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@33, 04272015@36

Distribution pattern

Nationwide

drug · product 191 of 382

PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1621-2015
Recall number
D-1621-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
209 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@31, 8/10/2015; 03132015@28, 9/9/2015; 03272015@5, 9/23/2015; 03262015@17, 9/22/2015; 03272015@17, 9/23/2015; 04012015@28, 9/28/2015

Distribution pattern

Nationwide

drug · product 192 of 382

PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1622-2015
Recall number
D-1622-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
195 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@32, 8/10/2015; 04012015@30, 9/28/2015; 04272015@38, 10/24/2015

Distribution pattern

Nationwide

drug · product 193 of 382

Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1623-2015
Recall number
D-1623-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
100 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05112015@18, 8/9/2015

Distribution pattern

Nationwide

drug · product 194 of 382

Polidocanol 1% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1624-2015
Recall number
D-1624-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
548 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04102015@36, 7/9/2015; 03252015@36, 6/23/2015; 04012015@77, 6/30/2015; 04162015@49, 7/15/2015; 04292015@83; 7/28/2015

Distribution pattern

Nationwide

drug · product 195 of 382

Polidocanol 5% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1625-2015
Recall number
D-1625-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
533 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05062015@45, 8/4/2015, 02272015@13, 5/28/2015, 03102015@46, 6/8/2015, 04172015@17, 7/16/2015

Distribution pattern

Nationwide

drug · product 196 of 382

Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1626-2015
Recall number
D-1626-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
18 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04292015@66, 10/26/2015

Distribution pattern

Nationwide

drug · product 197 of 382

Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Protect from Light, The Compounding Pharmacy of America, Knoxville, TN

D-1627-2015
Recall number
D-1627-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
196 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 03122015@6/102015; 03202015@29, 6/18/2015, 03232015@3, 6/21/2015

Distribution pattern

Nationwide

drug · product 198 of 382

Selenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1628-2015
Recall number
D-1628-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
229 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04162015@17, 7/15/2015; 03202015@25, 6/18/2015; 03272015@36, 6/25/2015; 04292015@89, 7/28/2015, and 05042015@52, 8/2/2015

Distribution pattern

Nationwide

drug · product 199 of 382

Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

D-1629-2015
Recall number
D-1629-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
77 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04092015@84, 6/8/2015; 04062015@55, 6/5/2015; 04222015@104, 6/21/2015; 04292015@47, 6/28/2015

Distribution pattern

Nationwide

drug · product 200 of 382

Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

D-1630-2015
Recall number
D-1630-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04092015@9, 6/8/2015; 04152015@59, 6/14/2015; 04042015@26, 6/6/2015; 04132015@36, 6/12/2015

Distribution pattern

Nationwide

drug · product 201 of 382

Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

D-1631-2015
Recall number
D-1631-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
185 ml total volume

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05072015@31, 7/6/2015; 03232015@11, 5/22/2015; 03302015@44, 5/29/2015; 03272015@16, 5/26/2015; 04222015@81, 6/1/2015; 04032015@15, 6/2/2015; 04142015@9, 6/13/2015; 04232015@11, 6/22/2015; 04272015@42, 6/26/2015; 04292015@86, 6/28/2015

Distribution pattern

Nationwide

drug · product 202 of 382

Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

D-1632-2015
Recall number
D-1632-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
41 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03242015@91, 5/23/2015; 04012015@50, 5/31/2015; 04242015, 6/23/2015

Distribution pattern

Nationwide

drug · product 203 of 382

Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

D-1633-2015
Recall number
D-1633-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
32 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04012015@76, 5/31/2015, 04062015@11, 6/5/2015

Distribution pattern

Nationwide

drug · product 204 of 382

Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1634-2015
Recall number
D-1634-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
4554 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04202015@78, 7/19/2015; 02242015@9, 5/25/2015; 03162015@75, 6/14/2015; 03312015@70, 6/29/2015; 04292015@87, 7/28/2015; 05042015@41, 8/2/2015; 04212015@16, 7/20/2015; 02242015@54, 5/25/2015; and 04222015@65, 7/21/2015

Distribution pattern

Nationwide

drug · product 205 of 382

Sodium Tetradecyl Sulfate 5% Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1635-2015
Recall number
D-1635-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
66 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03312015@58, 6/29/2015; and 04012015@68, 6/30/2015

Distribution pattern

Nationwide

drug · product 206 of 382

Sufentanil 45 mcg/ml + Bupivacaine 5 mg/ml Solution, Sterile=Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1636-2015
Recall number
D-1636-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 04142015@70, 7/13/2015

Distribution pattern

Nationwide

drug · product 207 of 382

Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1637-2015
Recall number
D-1637-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
159 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03112015@2, 6/9/2015; 03162015@6/14/2015; 03242015@2, 6/22/2015, 03302015@62, 6/28/2015, 0406201@43, 7/5/2015; 04142015@62, 7/13/2015, 04122015@6/20/2015

Distribution pattern

Nationwide

drug · product 208 of 382

Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1638-2015
Recall number
D-1638-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
200 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04212015@27, 6/2062015; 02272015@42, 5/28/2015; 03112015@3, 6/9/2015; 03162015@85, 6/14/2015; 03242015@3, 6/22/2015; 03302015@63, 6/28/2015, 04062015@44, 7/5/2015; 04142015@63, 7/13/2015; 04212015@28, 6/20/2015; and 05072015@8, 7/6/2015,

Distribution pattern

Nationwide

drug · product 209 of 382

SUPER LIPO Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1639-2015
Recall number
D-1639-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
394 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03312015@51, 6/11/2015; 04142015@18, 7/13/2015; 03302015, 6/28/2015; 04302015@48, 7/29/2015

Distribution pattern

Nationwide

drug · product 210 of 382

Testosterone Cypionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1640-2015
Recall number
D-1640-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
54 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05062015@65, 10/6/2015; 04162015@52, 10/13/2015; 03132015@16, 9/9/2015

Distribution pattern

Nationwide

drug · product 211 of 382

Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1641-2015
Recall number
D-1641-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
37 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 03202015@1, 9/16/2015, 01192015@54, 7/18/2015; 04082015@4, 10/5/2015

Distribution pattern

Nationwide

drug · product 212 of 382

Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1642-2015
Recall number
D-1642-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
9026 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01142015@3, 7/13/2015; 01142015@13, 7/13/2015; 03032015@47, 8/30/2015; 05042015@33, 10/31/2015; 11242014@30, 5/23/2015; 11242014@34, 5/23/2015; 12182014@79, 6/16/2015; 12232014@4, 6/21/2015; 01232015@28, 7/22/2015; 01142015@17, 7/13/2015; 01302015@6, 7/29/2015; 02022015@5, 8/1/2015; 04092015@10, 10/6/2015; 02162015@4, 8/15/2015; 02192015@19, 8/18/2015; 03032015@48, 8/30/2015; 03202015@100, 9/16/2015; 03202015@11, 9/16/2015; 04132015@18, 10/10/2015; 04202015@14, 10/17/2015; 03302015@12, 9/26/2015; 04062015@23, 10/3/2015; 04082015@10, 10/5/2015; 04242015@1, 10/21/2015; 04292015@29, 10/26/2015; 12012014@23, 5/30/2015; 03042015@50, 8/31/2015; 03262015@56, 9/22/2015; 04062015@21, 10/3/2015; 05012015@51, 10/28/2015; 11242014@8, 5/23/2015; 05052015@23, 11/1/2015; 12042014@54, 6/2/2015; 04102015@21, 10/7/2015; 01122015@41, 7/11/2015; 12162014@3, 6/14/2015; 12012014@28, 5/30/2015; 12052014@17, 6/3/2015; 12172014@34, 6/15/2015; 12192014@51, 6/17/2015; 01072015@7, 7/6/2015; 01182015@6, 7/17/2015; 01192015@4, 7/18/2015; 01232015@25, 7/22/2015; 01072015@61, 7/6/2015; 01192015@37, 7/18/2015; 01062015@3, 7/5/2015; 01302015@58, 7/29/2015; 01272015@22, 7/26/2015; 02022015@9, 8/1/2015; 02062015@1, 8/5/2015; 02102015@49, 8/9/2015; 02052015@37, 8/4/2015; 02052015@62, 8/4/2015; 02052015@71, 8/4/2015; 02062015@25, 8/5/2015; 02092015@66, 8/8/2015; 05072015@41, 11/3/2015; 02132015@2, 8/12/2015; 02232015@57, 8/22/2015; 02242015@16, 8/23/2015; 02192015@42, 8/18/2015; 04082015@26, 10/5/2015; 02272015@67, 8/26/2015; 03022015@75, 8/29/2015; 04082015@30, 10/5/2015; 03102015@2, 9/6/2015; 03032015@53, 8/30/2015; 03032015@55, 8/30/2015; 03062015@11, 9/2/2015; 03062015@31, 9/2/2015; 03192015@45, 9/15/2015; 03252015@47, 9/21/2015; 03272015@53, 9/23/2015; 04022015@1, 9/29/2015; 04022015@6, 9/29/2015; 04012015@75, 9/28/2015; 04202015@57, 10/17/2015; 04202015@61, 10/17/2015; 04212015@40, 10/18/2015; 04242015@9, 10/21/2015; 04282015@43, 10/25/2015; and 05052015@21, 11/1/2015

Distribution pattern

Nationwide

drug · product 213 of 382

Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1643-2015
Recall number
D-1643-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
13 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04172015@10/14/2015

Distribution pattern

Nationwide

drug · product 214 of 382

Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1644-2015
Recall number
D-1644-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
125 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04172015@56, 10/14/2015; 04202015@32, 10/17/2015; 049057, 10/21/2015; 05052015@69 11/1/2015; 05082015@43, 11/4/2015

Distribution pattern

Nationwide

drug · product 215 of 382

Testosterone Cypionate 200 mg/ml Anastrazole 2 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1645-2015
Recall number
D-1645-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
89 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015

Distribution pattern

Nationwide

drug · product 216 of 382

Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50,000 U/ml, Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1646-2015
Recall number
D-1646-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
13 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04202015@66, 10/17/2015

Distribution pattern

Nationwide

drug · product 217 of 382

Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1647-2015
Recall number
D-1647-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
120 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12022014@35, 5/31/2015; 01122015@40, 7/11/2015; 12312014@28, 6/29/2015; 03022015@71, 8/29/2015; 03122015@1, 9/8/2015; 04222015@2, 10/19/2015; 04282015@48, 10/25/2015

Distribution pattern

Nationwide

drug · product 218 of 382

Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1648-2015
Recall number
D-1648-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01122015@25, 7/11/2015; 02232015@48, 8/22/2015; 03242015@27, 9/20/2015

Distribution pattern

Nationwide

drug · product 219 of 382

Testosterone Propionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1649-2015
Recall number
D-1649-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04302015@39, 10/27/2015

Distribution pattern

Nationwide

drug · product 220 of 382

Testosterone USP (10 AQUEOUS) 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1650-2015
Recall number
D-1650-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
49 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01122015@25, 7/11/2015; 02232015@48, 8/22/2015; 03242015, 9/20/2015

Distribution pattern

Nationwide

drug · product 221 of 382

Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN

D-1651-2015
Recall number
D-1651-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
216 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12032014@47, 6/1/2015; 12052014@36, 6/3/2015; 12192014@33, 6/17/2015; 01202015@53, 7/19/2015; 01062015@58, 7/5/2015; 02122015@40, 8/11/2015; 03022015@15, 8/29/2015; 03252015@22, 9/21/2015; 05082015@6, 11/4/2015

Distribution pattern

Nationwide

drug · product 222 of 382

Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

D-1652-2015
Recall number
D-1652-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
24 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 05062015@31, 11/2/2015

Distribution pattern

Nationwide

drug · product 223 of 382

Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

D-1653-2015
Recall number
D-1653-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
60 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12182014@19, 6/16/2015; 03192015@38, 9/15/2015; 04072015@9, 10/4/2015

Distribution pattern

Nationwide

drug · product 224 of 382

Testosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

D-1654-2015
Recall number
D-1654-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
96 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01122015@63, 7/11/2015; 03162015@9, 9/12/2015; 03232015@13, 9/19/2015; 05012015@23, 10/28/2015

Distribution pattern

Nationwide

drug · product 225 of 382

Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

D-1655-2015
Recall number
D-1655-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
192 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05072015@42, 11/3/2015; 12292014@9, 6/27/2015; 12032014@12, 6/1/2015; 12042014@73, 6/2/2015; 02272015@63, 8/26/2015; 05042015@44, 10/31/2015; 03302015@9, 9/26/2015; 04092015@46, 10/6/2015

Distribution pattern

Nationwide

drug · product 226 of 382

Testosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

D-1656-2015
Recall number
D-1656-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
72 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 11212014@51, 5/20/2015; 02232015@24, 8/22/2015; 05062015@27, 11/2/2015

Distribution pattern

Nationwide

drug · product 227 of 382

Testosterone 60 mg Anastrazole 4 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

D-1657-2015
Recall number
D-1657-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
85 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12032014@36, 6/1/2015; 12082014@22, 6/6/2015; 01202015@19, 7/19/2015; 05042015@81, 10/31/2015; 05112015@19, 11/7/2015; 04282015@44, 10/25/2015

Distribution pattern

Nationwide

drug · product 228 of 382

Testosterone 200 mg Anastrazole 1 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

D-1658-2015
Recall number
D-1658-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
10 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@38, 9/12/2015

Distribution pattern

Nationwide

drug · product 229 of 382

Testosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

D-1659-2015
Recall number
D-1659-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
94 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01292015@32, 7/28/2015; 02232015@18, 5/20/2015; 02272015@31, 8/26/2015; 03092015@23, 9/5/2015; 03272015@32, 9/23/2015

Distribution pattern

Nationwide

drug · product 230 of 382

Testosterone 75 mg and B12 6 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

D-1660-2015
Recall number
D-1660-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1 pellet

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02242015@49, 8/23/2015

Distribution pattern

Nationwide

drug · product 231 of 382

Vancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1661-2015
Recall number
D-1661-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
28 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03102015@34 6/8/2015; 03042015@43, 6/2/2015

Distribution pattern

Nationwide

drug · product 232 of 382

Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1662-2015
Recall number
D-1662-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04292015@91, 7/28/2015

Distribution pattern

Nationwide

drug · product 233 of 382

Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1663-2015
Recall number
D-1663-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
130 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05042015@54, 8/2/2015

Distribution pattern

Nationwide

drug · product 234 of 382

Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1664-2015
Recall number
D-1664-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
112 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@40, 8/10/2015; 03132015@26, 7/20/2015; 04012015@11, 9/28/2015; 04272015@51, 10/24/2015

Distribution pattern

Nationwide

drug · product 235 of 382

Bi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1665-2015
Recall number
D-1665-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@34, 9/5/2015

Distribution pattern

Nationwide

drug · product 236 of 382

Bi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1666-2015
Recall number
D-1666-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12022014@48, 5/31/2015

Distribution pattern

Nationwide

drug · product 237 of 382

Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1667-2015
Recall number
D-1667-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
426 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03232015@2, 6/21/2015; 05052015@8, 8/3/2015; 04222015@7, 7/21/2015

Distribution pattern

Nationwide

drug · product 238 of 382

Calmme Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1668-2015
Recall number
D-1668-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
296 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03232015@1, 6/21/2015; 04222015@8, 7/21/2015; 05052015@7, 8/3/2015

Distribution pattern

Nationwide

drug · product 239 of 382

Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution, Sterile-reservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1669-2015
Recall number
D-1669-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
86 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 04142015@68, 7/13/2015; 03162015@67, 5/20/2015

Distribution pattern

Nationwide

drug · product 240 of 382

Hydromorphone 20 mg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1670-2015
Recall number
D-1670-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@8, 6/14/2015

Distribution pattern

Nationwide

drug · product 241 of 382

Hydromorphone 3 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1671-2015
Recall number
D-1671-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
67 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@5, 5/31/2015; 03202015@53, 6/18/2015; 04172015@37, 6/16/2015

Distribution pattern

Nationwide

drug · product 242 of 382

Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1672-2015
Recall number
D-1672-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03242015@81, 6/22/2015

Distribution pattern

Nationwide

drug · product 243 of 382

Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1673-2015
Recall number
D-1673-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03232015@18, 6/21/2015

Distribution pattern

Nationwide

drug · product 244 of 382

Hydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1674-2015
Recall number
D-1674-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
67 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@8, 5/31/2015, 03202015@60, 6/18/2015; 04172015@29, 6/16/2015

Distribution pattern

Nationwide

drug · product 245 of 382

Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1675-2015
Recall number
D-1675-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
23 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04072015@70, 7/6/2015

Distribution pattern

Nationwide

drug · product 246 of 382

Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1676-2015
Recall number
D-1676-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
45 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@21, 6/10/2015; 04092015@71, 6/8/2015

Distribution pattern

Nationwide

drug · product 247 of 382

Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1677-2015
Recall number
D-1677-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
45 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@61, 6/18/2015; 04172015@38, 6/16/2015

Distribution pattern

Nationwide

drug · product 248 of 382

Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200 mcg/ml + Baclofen 90 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1678-2015
Recall number
D-1678-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
66 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@17, 6/7/2015, 04032015@26, 7/2/2015; 5012015@15, 7/30/2015

Distribution pattern

Nationwide

drug · product 249 of 382

Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100 mcg/ml + Baclofen 600 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1679-2015
Recall number
D-1679-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
67 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@7, 5/31/2015; 03202015@59, 6/18/2015; 04172015@39, 6/16/2015

Distribution pattern

Nationwide

drug · product 250 of 382

Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1680-2015
Recall number
D-1680-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@19, 6/10/2015; 04242015@48, 7/23/2015

Distribution pattern

Nationwide

drug · product 251 of 382

Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1681-2015
Recall number
D-1681-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@24, 6/10/2015

Distribution pattern

Nationwide

drug · product 252 of 382

Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1682-2015
Recall number
D-1682-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@58, 6/18/2015

Distribution pattern

Nationwide

drug · product 253 of 382

Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1683-2015
Recall number
D-1683-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1200 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04222015@13, 7/21/2015; 05112015@74, 8/9/2015

Distribution pattern

Nationwide

drug · product 254 of 382

Lipo-DEN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1684-2015
Recall number
D-1684-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
2733 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@26, 5/31/2015; 02272015@22, 5/28/2015; 03092015@75, 6/7/2015; 04092015@97, 7/8/2015; 04092015@37, 7/8/2015; 03022015@78, 5/31/2015; 04102015@6, 7/9/2015; 04242015@31, 7/23/2015

Distribution pattern

Nationwide

drug · product 255 of 382

LIPO-DEN MODIFIED Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1685-2015
Recall number
D-1685-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1650 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@68, 5/31/2015; 04102015@4, 7/9/2015; 04242015@23, 7/23/2015

Distribution pattern

Nationwide

drug · product 256 of 382

LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1686-2015
Recall number
D-1686-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
105 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@79, 6/10/2015

Distribution pattern

Nationwide

drug · product 257 of 382

LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1687-2015
Recall number
D-1687-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
305 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02262015@3, 5/27/2015

Distribution pattern

Nationwide

drug · product 258 of 382

LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1688-2015
Recall number
D-1688-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
2804 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@27, 5/31/2015; 02242015@4, 5/25/2015; 02272015@4, 5/28/2015; 03052015@1, 6/3/2015; 03132015@49, 6/11/2015; 03162015@29, 6/14/2015; 03182015@1, 6/16/2015; 03172015@13, 6/15/2015; 03172015@17, 6/15/2015; 03172015@20, 6/15/2015; 03182015@18, 6/16/2015; 03232015@14, 6/21/2015; 04272015@57, 7/26/2015; 03302015@31, 6/28/2015; 04092015@24, 7/8/2015; 03312015@46, 6/29/2015; 03312015@55, 6/29/2015; 04022015@61, 7/1/2015; 04032015@17, 7/2/2015; 04072015@11, 7/6/2015; 04072015@11, 7/6/2015; 04102015@51, 7/9/2015; 04142015@69, 7/13/2015; 04142015@83, 7/13/2015; 04212015@6, 7/20/2015; 05052015@95, 8/3/2015; 04222015@50, 7/21/2015; 05042015@26, 8/2/2015; 04292015@5, 7/28/2015; 04272015@50, 7/26/2015; 04302015@37, 7/29/2015; 05012015@39, 7/30/2015; 05112015@24, 8/9/2015

Distribution pattern

Nationwide

drug · product 259 of 382

LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1689-2015
Recall number
D-1689-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
620 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02232015@72, 5/24/2015; 02252015@60, 5/26/2015; 03112015@55, 6/9/2015; 03122015@99, 6/10/2015; 03172015@67, 6/15/2015; 03312015@74, 6/29/2015; 05052015@34, 8/3/2015; 04292015@21, 7/28/2015

Distribution pattern

Nationwide

drug · product 260 of 382

Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1690-2015
Recall number
D-1690-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
775 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05062015@1, 7/31/2015; 04152015@62, 7/14/2015; 03232015@53, 6/21/2015; 03232015@75, 6/21/2015; 04152015@11, 7/14/2015

Distribution pattern

Nationwide

drug · product 261 of 382

Lipotropic B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1691-2015
Recall number
D-1691-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
249 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03042015@17, 6/2/2015; 04142015@20, 7/13/2015; 03192015@51, 6/17/2015; 04142015@89, 7/13/2015; 04232015@3, 7/22/2015

Distribution pattern

Nationwide

drug · product 262 of 382

Lipotropic B-12 II* + Lidocaine Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1692-2015
Recall number
D-1692-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
520 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04132015@63, 7/12/2015; 03182015@34, 6/16/2015; 05082015@26, 8/6/2015

Distribution pattern

Nationwide

drug · product 263 of 382

Lipotropic Methyl B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1693-2015
Recall number
D-1693-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
128 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03102015@62, 6/8/2015; 03172015@52, 6/15/2015; 03272015@8, 6/25/2015

Distribution pattern

Nationwide

drug · product 264 of 382

Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1694-2015
Recall number
D-1694-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
331 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04152015@29; 7/14/2015; 04212015@31, 7/20/2015

Distribution pattern

Nationwide

drug · product 265 of 382

Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1695-2015
Recall number
D-1695-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
480 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03182015@17, 6/16/2015

Distribution pattern

Nationwide

drug · product 266 of 382

MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1696-2015
Recall number
D-1696-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
3513 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04212015@10, 7/20/2015; 02232015@86, 5/24/2015; 02252015@79, 5/26/2015; 03112015@21, 6/9/2015; 03232015@40, 6/21/2015; 03242015@76, 6/22/2015; 03312015@60, 6/29/2015; 03272015@27, 6/25/2015; 04022015@62, 7/1/2015; 04072015@55, 7/6/2015; 04142015@59, 7/13/2015; 04212015@30, 7/20/2015; 04212015@54, 7/20/2015; 04222015@31, 7/21/2015; 05042015@64, 8/2/2015; 05052015@60, 8/3/2015; 04272015@77, 7/26/2015; 04292015@14, 7/28/2015; 04292015@23, 7/28/2015; 05052015@92, 8/3/2015; 05082015@23, 8/6/2015; 05012015@11, 7/30/2015; 05052015@98, 8/3/2015

Distribution pattern

Nationwide

drug · product 267 of 382

MEGA-BURN Injectable ROCK CREEK, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1697-2015
Recall number
D-1697-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
461 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02272015@77, 5/28/2015; 03122015@85, 6/10/2015; 03252015@29, 6/23/2015; 04072015@54, 7/6/2015; 04172015@69, 7/16/2015; 04272015@45, 7/26/2015

Distribution pattern

Nationwide

drug · product 268 of 382

MEGA-BURN IV Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1698-2015
Recall number
D-1698-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
428 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04142015@6, 7/13/2015; 03132015@9, 6/11/2015; 03122015@100, 6/10/2015; 04142015@15, 7/13/2015; 03302015@46, 6/28/2015; 04302015@49, 7/29/2015

Distribution pattern

Nationwide

drug · product 269 of 382

MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1699-2015
Recall number
D-1699-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1436 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@28, 5/31/2015; 04152015@17, 7/14/2015; 04152015@44, 7/14/2015; 02272015@62, 5/28/2015; 03032015@25, 6/1/2015; 03122015@89, 6/10/2015; 03162015@58, 6/14/2015; 03182015@28, 6/16/2015; 03302015@26, 6/28/2015; 04062015@65, 7/5/2015; 04142015@45, 7/13/2015; 04172015@46, 7/16/2015; 04242015@27, 7/23/2015; 04292015@31, 7/28/2015; 04292015@81, 7/28/2015; 5082015@63, 8/6/2015; 04302015@9, 7/29/2015; 05112015@30, 8/9/2015; 5072015@14, 8/5/2015

Distribution pattern

Nationwide

drug · product 270 of 382

MEGA-BURN* Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1700-2015
Recall number
D-1700-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
134 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@61, 5/31/2015; 03052015@11, 6/3/2015; 04132015@21, 7/12/2015; 03242015@7, 6/22/2015; 04292015@11, 7/28/2015

Distribution pattern

Nationwide

drug · product 271 of 382

Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1701-2015
Recall number
D-1701-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@14, 6/7/2015; 04242015@54, 7/23/2015

Distribution pattern

Nationwide

drug · product 272 of 382

Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1702-2015
Recall number
D-1702-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@84, 6/18/2015

Distribution pattern

Nationwide

drug · product 273 of 382

Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1703-2015
Recall number
D-1703-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
66 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02272015@35, 5/28/2015; 04222015@23, 7/21/2015

Distribution pattern

Nationwide

drug · product 274 of 382

Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1704-2015
Recall number
D-1704-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04012015@6, 6/30/2015

Distribution pattern

Nationwide

drug · product 275 of 382

Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1705-2015
Recall number
D-1705-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@25, 6/7/2015; 04242015@44, 7/23/2015

Distribution pattern

Nationwide

drug · product 276 of 382

Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1706-2015
Recall number
D-1706-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
129 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@12, 5/20/2015; 03242015@80, 6/22/2015; 04222015@24, 7/21/2015

Distribution pattern

Nationwide

drug · product 277 of 382

Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1707-2015
Recall number
D-1707-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03092015@15, 6/7/2015; 04092015@69, 6/8/2015; 05012015@12, 6/30/2015

Distribution pattern

Nationwide

drug · product 278 of 382

Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 mcg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1708-2015
Recall number
D-1708-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
86 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@70, 6/14/2015; 04142015@72, 5/20/2015

Distribution pattern

Nationwide

drug · product 279 of 382

Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1709-2015
Recall number
D-1709-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03202015@57, 6/18/2015; 04242015@53, 7/23/2015

Distribution pattern

Nationwide

drug · product 280 of 382

Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 15 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1710-2015
Recall number
D-1710-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
70 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05082015@38, 7/7/2015; 03122015@15, 6/10/2015; 04092015@72, 6/8/2015

Distribution pattern

Nationwide

drug · product 281 of 382

Morphine 50 mg/ml + Ropivacaine 5 mg/ml +Baclofen 20 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1711-2015
Recall number
D-1711-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04072015@69, 7/6/2015

Distribution pattern

Nationwide

drug · product 282 of 382

Morphine 50 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1712-2015
Recall number
D-1712-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
70 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@23, 6/10/2015; 04092015@73, 6/8/2015; 05082015@39, 7/7/2015

Distribution pattern

Nationwide

drug · product 283 of 382

Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,400 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1713-2015
Recall number
D-1713-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@69, 6/14/2015

Distribution pattern

Nationwide

drug · product 284 of 382

Myers Cocktail Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1714-2015
Recall number
D-1714-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
185 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05072015@9, 6/11/2015; 05062015@39, 6/10/2015

Distribution pattern

Nationwide

drug · product 285 of 382

MYO-DEN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1715-2015
Recall number
D-1715-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
13 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03062015@29, 6/4/2015; 02192015@44, 5/20/2015; 03162015@87, 6/14/2015

Distribution pattern

Nationwide

drug · product 286 of 382

Quad-Mix 1 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1716-2015
Recall number
D-1716-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@26, 8/10/2015

Distribution pattern

Nationwide

drug · product 287 of 382

Quad-Mix 2 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1717-2015
Recall number
D-1717-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05052015@16, 11/1/2015

Distribution pattern

Nationwide

drug · product 288 of 382

Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1718-2015
Recall number
D-1718-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
45 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@27, 8/10/2015; 02032015@93, 8/2/2015

Distribution pattern

Nationwide

drug · product 289 of 382

TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1719-2015
Recall number
D-1719-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
13 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03042015@7, 8/31/2015

Distribution pattern

Nationwide

drug · product 290 of 382

Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1720-2015
Recall number
D-1720-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01202015@30, 7/19/2015; 01262015@22, 7/25/2015; 02092015@14, 7/1/2015; 02192015@12, 8/18/2015; 03202015@86, 9/16/2015; 03232015@25, 9/19/2015; 04282015@14, 10/25/2015; 04282015@18, 10/25/2015

Distribution pattern

Nationwide

drug · product 291 of 382

Tri-Mix Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1721-2015
Recall number
D-1721-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
160.75 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015

Distribution pattern

Nationwide

drug · product 292 of 382

Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1722-2015
Recall number
D-1722-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01212015@40, 7/20/2015

Distribution pattern

Nationwide

drug · product 293 of 382

Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1723-2015
Recall number
D-1723-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
3215 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04102015@70, 7/9/2015; 04212015@9, 7/20/2015; 04092015@75, 7/8/2015; 03022015@1, 5/31/2015; 04202015@12, 7/19/2015; 03112015@19, 6/9/2015; 03032015@36, 6/1/2015; 03032015@40, 6/1/2015; 03062015@28, 6/4/2015; 03192015@5, 6/17/2015; 03202015@15, 6/18/2015; 03172015@18, 6/15/2015; 03172015@27, 7/13/2015; 03202015@87, 6/18/2015; 03242015@35, 6/22/2015; 05042015@76, 8/2/2015; 03272015@9, 6/25/2015; 03312015@14, 6/29/2015; 03272015@33, 6/25/2015; 03272015@43, 6/25/2015; 04012015@37, 6/30/2015; 04022015@32, 7/1/2015; 04162015@39, 7/15/2015; 04232015@5, 7/22/2015; 04212015@65, 7/20/2015; 04222015@48, 7/21/2015; 04272015@65, 7/26/2015; 05052015@96, 8/3/2015; 05012015@34, 7/30/2015; 05052015@87, 8/3/2015; 05072015@53, 8/5/2015

Distribution pattern

Nationwide

drug · product 294 of 382

Vitatrim Active Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1724-2015
Recall number
D-1724-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
761 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04152015@28, 7/14/2015; 04212015@29, 7/20/2015; 04212015@37, 7/20/2015; 04172015@10, 7/16/2015

Distribution pattern

Nationwide

drug · product 295 of 382

Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1725-2015
Recall number
D-1725-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
100 ML

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04022015@36, 7/1/2015

Distribution pattern

Nationwide

drug · product 296 of 382

B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1726-2015
Recall number
D-1726-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 ML

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02202015@47 5/21/2015

Distribution pattern

Nationwide

drug · product 297 of 382

Betamethasone Sodium Phosphate (10 ml) 30 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1727-2015
Recall number
D-1727-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
13 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12122015@76, 6/10/2015

Distribution pattern

Nationwide

drug · product 298 of 382

Fentanyl 5,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1728-2015
Recall number
D-1728-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@82, 5/31/2015; 03202015@69, 6/18/2015

Distribution pattern

Nationwide

drug · product 299 of 382

Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine 1,000 mcg/ml+Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1729-2015
Recall number
D-1729-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
48 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04092015@82, 6/8/2015; 05082015@37, 7/7/2015

Distribution pattern

Nationwide

drug · product 300 of 382

Hydromorphone 80 mg/ml + Clonidine 1,800 mcg/ml + Baclofen 730 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN

D-1730-2015
Recall number
D-1730-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04242015@52, 7/23/2015

Distribution pattern

Nationwide

drug · product 301 of 382

Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN

D-1731-2015
Recall number
D-1731-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
70 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@6, 5/31/2015; 04172015@25, 6/16/2015; 05082015@35, 7/7/2015

Distribution pattern

Nationwide

drug · product 302 of 382

Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN

D-1732-2015
Recall number
D-1732-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
22 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04272015@27, 6/26/2015

Distribution pattern

Nationwide

drug · product 303 of 382

LIPOLEAN Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1733-2015
Recall number
D-1733-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1830 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05082015@29, 8/6/2015; 04022015@43, 7/1/2015; 04242015@32, 7/23/2015; 04282015@37, 7/27/2015; 04292015@97, 7/28/2015; 04302015@61, 7/29/2015

Distribution pattern

Nationwide

drug · product 304 of 382

LIPOLEAN + Ascorbic Acid 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1734-2015
Recall number
D-1734-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
33 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04132015@56, 7/12/2015

Distribution pattern

Nationwide

drug · product 305 of 382

MEGA-BURN, Winning at Weight Loss Formula Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1735-2015
Recall number
D-1735-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
200 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04292015@11, 7/28/2015

Distribution pattern

Nationwide

drug · product 306 of 382

Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1736-2015
Recall number
D-1736-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
359 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02252015@3, 5/26/2015; 03022015@17, 5/31/2015; 03162015@60, 6/14/2015; 04012015@1, 6/30/2015; 04142015@66, 7/13/2015; 04272015@28, 6/26/2015

Distribution pattern

Nationwide

drug · product 307 of 382

Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1737-2015
Recall number
D-1737-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03162015@6, 6/14/2015

Distribution pattern

Nationwide

drug · product 308 of 382

Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1738-2015
Recall number
D-1738-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
43 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 03162015@7, 6/14/2015

Distribution pattern

Nationwide

drug · product 309 of 382

MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1739-2015
Recall number
D-1739-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
218 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02192015@44, 5/20/2015; 03162015@87, 6/14/2015

Distribution pattern

Nationwide

drug · product 310 of 382

PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1740-2015
Recall number
D-1740-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
25 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04282015@46, 10/25/2015; 04302015@31, 10/27/2015; 05072015@36, 11/3/2015

Distribution pattern

Nationwide

drug · product 311 of 382

Testosterone 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1741-2015
Recall number
D-1741-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
24 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02092015@20, 8/8/2015

Distribution pattern

Nationwide

drug · product 312 of 382

Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1742-2015
Recall number
D-1742-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
1222 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01082015@1, 7/7/2015; 11212014@6, 5/20/2015; 11212014@8, 5/20/2015; 1242014@51, 5/23/2015, 11262014@72, 5/25/2015, 01152015@29, 7/14/2015; 02112015@12, 8/10/2015; 12192014@6, 6/17/2015; 12012014@57, 5/30/2015; 12022014@33; 5/31/2015; 12042014@50, 6/2/2015; 12152014@10, 6/13/2015; 12082014@38; 6/6/2015; 12182014@18, 6/16/2015; 12092014@62, 6/7/2015; 12292014@37, 6/27/2015; 12292014@72, 6/29/2015; 01222015@44, 7/21/2015; 01052015@3, 7/4/2015; 01092015@9, 7/8/2015; 01202015@42; 7/19/2015; 04212015@11, 10/18/2015; 01272015@40, 7/26/2015; 01292015@25, 7/28/2015; 01282015@30, 7/27/2015; 02102015@34, 8/9/2015; 02092015@29, 8/8/2015; 02132015@26, 8/12/2015; 02232015@10, 8/22/2015; 02242015@13, 8/23/2015; 02162015@28, 8/15/2015; 04102015@38, 10/7/2015; 05042015@34, 10/31/2015; 02272015@29, 8/26/2015, 03032015@16, 8/30/2015, 03112015@34, 9/7/2015; 03182015@26, 9/14/2015; 03272015@29; 9/23/2015; 04012015@5, 9/28/2015, 04062015@16, 10/3/2015; 04032015@57, 9/30/2015; 04212015@42; 10/18/2015; 05012015@6, 10/28/2015; 05072015@57, 11/3/2015; 05042015@13, 10/31/2015; 04272015@39, 10/24/2015, 04282015@60, 10/25/2015; 05062015@14, 11/2/2015; 05112015@28, 11/7/2015

Distribution pattern

Nationwide

drug · product 313 of 382

Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1743-2015
Recall number
D-1743-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
144 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 11262014@67, 5/25/2015; 03022015@70, 8/29/2015; 01052015@50, 7/4/2015; 02052015@72, 8/4/2015; 04302015@53, 10/27/2015

Distribution pattern

Nationwide

drug · product 314 of 382

Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1744-2015
Recall number
D-1744-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
24 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03032015@43, 8/30/2015

Distribution pattern

Nationwide

drug · product 315 of 382

Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1745-2015
Recall number
D-1745-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
510 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12122014@8, 6/10/2015; 12042014@47, 6/2/2015; 01122015@54, 7/11/2015; 04142015@82, 10/11/2015; 01072015@32, 7/6/2015; 01192015@17, 7/18/2015; 02042015@43, 8/3/2015; 02232015@35, 8/22/2015; 02272015@30, 8/26/2015; 02272015@19, 8/26/2015; 03162015@55, 9/12/2015; 03192015@23, 9/15/2015; 03192015@33, 9/15/2015; 04012015@55, 9/28/2015; 04072015@42, 10/4/2015, 04072015@6, 10/4/2015; 04102015@46, 10/7/2015; 04162015@56, 10/13/2015; 04282015@7, 10/25/2015, 04272015@59, 10/24/2015; 04302015@59, 10/27/2015

Distribution pattern

Nationwide

drug · product 316 of 382

Testosterone 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1746-2015
Recall number
D-1746-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
240 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12102014@3, 6/8/2015; 12042014@62, 6/2/2015; 01192015@15, 7/18/2015; 01062015@12, 7/5/2015; 02202015@23, 8/19/2015; 02242015@35, 8/23/2015; 03032015@17, 8/30/2015; 03252015@9, 9/21/2015; 04292015@19, 10/26/2015

Distribution pattern

Nationwide

drug · product 317 of 382

Testosterone 30 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1747-2015
Recall number
D-1747-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
24 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02192015@41, 8/18/2015

Distribution pattern

Nationwide

drug · product 318 of 382

Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1748-2015
Recall number
D-1748-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
144 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@79, 8/29/2015; 12092014@5, 6/7/2015; 12042014@28, 6/2/2015; 01152015@30, 7/14/2015; 04152015@24, 10/12/2015

Distribution pattern

Nationwide

drug · product 319 of 382

Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1749-2015
Recall number
D-1749-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
24 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04282015@24, 10/25/2015

Distribution pattern

Nationwide

drug · product 320 of 382

Testosterone 70 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1750-2015
Recall number
D-1750-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
60 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12182014@19, 6/16/2015; 03192015@38, 9/15/2015; 04072015@9, 10/4/2015

Distribution pattern

Nationwide

drug · product 321 of 382

Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1751-2015
Recall number
D-1751-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
265 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@60, 8/29/2015; 12042014@65, 6/2/2015; 12182014@39, 6/16/2015; 01152015@37, 7/14/2015; 01052015@1, 7/4/2015; 02052015@50, 8/4/2015; 02132015@14, 8/12/2015; 03162015@14, 9/12/2015; 03252015@14, 9/21/2015; 04222015@44, 10/19/2015, 05042015@28, 10/31/2015

Distribution pattern

Nationwide

drug · product 322 of 382

Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 5 mg/ml Injection, Multi-Dose Vial,Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1752-2015
Recall number
D-1752-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 03252015@48, 9/21/15

Distribution pattern

Nationwide

drug · product 323 of 382

Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1753-2015
Recall number
D-1753-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03252015@48, 9/21/2015

Distribution pattern

Nationwide

drug · product 324 of 382

Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1754-2015
Recall number
D-1754-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02022015@1, 8/1/2015

Distribution pattern

Nationwide

drug · product 325 of 382

Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1755-2015
Recall number
D-1755-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
44 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01222015@34, 7/21/2015; 03172015@80, 9/13/2015; 04092015@65, 10/6/2015

Distribution pattern

Nationwide

drug · product 326 of 382

Testosterone Cypionate 220 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1756-2015
Recall number
D-1756-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
138 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 11242014@36, 5/23/2015; 12042014@53, 6/2/2015; 12222014@67, 6/20/2015; 02192015@5, 8/18/2015, 05042015@77, 10/31/2015; 05052015@54, 11/1/2015

Distribution pattern

Nationwide

drug · product 327 of 382

Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil), Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1757-2015
Recall number
D-1757-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
45 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04092015@12, 10/6/2015; 03122015@13, 9/8/2015

Distribution pattern

Nationwide

drug · product 328 of 382

Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1758-2015
Recall number
D-1758-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01292015@59, 7/28/2015

Distribution pattern

Nationwide

drug · product 329 of 382

Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmacy of America, Knoxville, TN

D-1759-2015
Recall number
D-1759-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
7 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04152015@56, 10/12/2015

Distribution pattern

Nationwide

drug · product 330 of 382

Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy of America, Knoxville, TN

D-1760-2015
Recall number
D-1760-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
15 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01122015@49, 7/11/2015

Distribution pattern

Nationwide

drug · product 331 of 382

Tri-Mix (10/0.174/16) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1761-2015
Recall number
D-1761-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04142015@61, 10/11/2015

Distribution pattern

Nationwide

drug · product 332 of 382

Tri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1762-2015
Recall number
D-1762-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
7 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01212015@40, 7/20/2015

Distribution pattern

Nationwide

drug · product 333 of 382

Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1763-2015
Recall number
D-1763-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
25 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05072015@6, 11/3/2015, 05052015@77, 11/1/2015

Distribution pattern

Nationwide

drug · product 334 of 382

Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1764-2015
Recall number
D-1764-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
307 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01082015@10, 7/7/2015; 12022014@44, 5/31/2015; 12192014@14, 6/17/2015; 01072015@22, 7/6/2015; 01262015@83, 7/25/2015; 02092015@12, 8/8/2015 02132015@5, 8/12/2015; 02202015@19, 8/19/2015; 02192015@24, 8/18/2015; 03022015@49, 8/29/2015; 03302015@1, 9/26/2015; 03312015@12, 9/27/2015; 04012015@63, 9/28/2015; 04162015@37, 10/13/2015; 05042015@37, 10/31/2015

Distribution pattern

Nationwide

drug · product 335 of 382

Tri-Mix (17.7 mg/1 mg/10 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1765-2015
Recall number
D-1765-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
14 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 05012015@2, 10/28/2015; 02232015@9, 8/22/2015

Distribution pattern

Nationwide

drug · product 336 of 382

Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1766-2015
Recall number
D-1766-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
62 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01082015@10, 7/7/2015; 12192014@10, 6/17/2015; 12022014@4, 5/31/2015; 12302014@56, 6/28/2015; 01262015@84, 7/25/2015, 03302015@51, 9/26/2015; 05052015@83, 11/1/2015

Distribution pattern

Nationwide

drug · product 337 of 382

Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1767-2015
Recall number
D-1767-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
13 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01262015@6, 7/25/2015

Distribution pattern

Nationwide

drug · product 338 of 382

Tri-Mix (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1768-2015
Recall number
D-1768-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
13 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01232015@45, 7/22/2015

Distribution pattern

Nationwide

drug · product 339 of 382

Tri-Mix (20/1/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1769-2015
Recall number
D-1769-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
6 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04292015@78, 10/26/2015

Distribution pattern

Nationwide

drug · product 340 of 382

Tri-Mix (20/2.5/20) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1770-2015
Recall number
D-1770-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
26 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03102015@57 9/6/2015 03092015@71 9/5/2015

Distribution pattern

Nationwide

drug · product 341 of 382

Tri-Mix (22.5/0.83/8.3) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1771-2015
Recall number
D-1771-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01272015@51, 7/26/2015

Distribution pattern

Nationwide

drug · product 342 of 382

Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1772-2015
Recall number
D-1772-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
19 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01202015@49, 7/19/2015; 04082015@12, 10/5/2015; 04282015@6, 10/25/2015

Distribution pattern

Nationwide

drug · product 343 of 382

Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1773-2015
Recall number
D-1773-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01202015@32, 7/19/2015

Distribution pattern

Nationwide

drug · product 344 of 382

Tri-Mix (30/0.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1774-2015
Recall number
D-1774-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
7 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01262015@50, 7/25/2015

Distribution pattern

Nationwide

drug · product 345 of 382

Tri-Mix (30/0.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1775-2015
Recall number
D-1775-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12302014@48, 6/28/2015

Distribution pattern

Nationwide

drug · product 346 of 382

Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1776-2015
Recall number
D-1776-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
139 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01302015@29, 7/29/2015; 04162015@31, 10/13/2015, 12162014@27, 6/14/2015; 01192015@8, 7/18/2015; 01142015@29, 7/13/2015; 01262015@49, 7/25/2015; 01092015@32, 7/8/2015; 01292015@37, 7/28/2015, 02112015@30, 8/10/2015; 02262015@5, 8/25/2015; 02272015@73, 8/26/2015; 03032015@18, 8/30/2015; 03062015@32, 9/2/2015; 03192015@44, 9/15/2015; 03302015@15, 9/26/2015; 04082015@8, 10/5/2015; 04062015@49, 10/3/2015; 04222015@81, 10/19/2015; 04302015@36, 10/27/2015; 05052015@41, 11/1/2015

Distribution pattern

Nationwide

drug · product 347 of 382

Tri-Mix (30/1/10) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1777-2015
Recall number
D-1777-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
27 ml total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12022014@50, 5/31/2015; 01092015@31, 7/8/2015; 02102015@43, 8/9/2015; 03272015@42, 9/23/2015

Distribution pattern

Nationwide

drug · product 348 of 382

Tri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1778-2015
Recall number
D-1778-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
16 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05082015@94, 11/4/2015

Distribution pattern

Nationwide

drug · product 349 of 382

Tri-Mix (30/1/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1779-2015
Recall number
D-1779-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05082015@31, 11/4/2015

Distribution pattern

Nationwide

drug · product 350 of 382

Tri-Mix (30/1/22) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1780-2015
Recall number
D-1780-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
14 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03112015@1, 9/7/2015; 01272015@24, 7/26/2015

Distribution pattern

Nationwide

drug · product 351 of 382

Tri-Mix (30/1/22) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1781-2015
Recall number
D-1781-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
14 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01272015@21, 7/26/2015; 03102015@52, 9/6/2015

Distribution pattern

Nationwide

drug · product 352 of 382

Tri-Mix (30/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1782-2015
Recall number
D-1782-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
32 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 03042015@5, 8/31/2015; 03122015@51, 9/8/2015; 04072015@27, 10/4/2015

Distribution pattern

Nationwide

drug · product 353 of 382

Tri-Mix (30/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1783-2015
Recall number
D-1783-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
7 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03122015@17, 9/8/2015

Distribution pattern

Nationwide

drug · product 354 of 382

Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1784-2015
Recall number
D-1784-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
13 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 03042015@18, 8/31/2015

Distribution pattern

Nationwide

drug · product 355 of 382

Tri-Mix (37.5/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1785-2015
Recall number
D-1785-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
25 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01162015@4, 7/15/2015; 02272015@47, 8/26/2015

Distribution pattern

Nationwide

drug · product 356 of 382

Tri-Mix (37.5/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1786-2015
Recall number
D-1786-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
38 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01152015@60, 7/14/2015; 02272015@34, 8/26/2015; 04012015@27, 9/28/2015

Distribution pattern

Nationwide

drug · product 357 of 382

Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1787-2015
Recall number
D-1787-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
6 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04132015@17, 10/10/2015

Distribution pattern

Nationwide

drug · product 358 of 382

Tri-Mix AT-1 (8 mg/2 mg/0.2 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1788-2015
Recall number
D-1788-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
12 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04012015@57, 9/28/2015

Distribution pattern

Nationwide

drug · product 359 of 382

Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1789-2015
Recall number
D-1789-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
70 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@39, 8/10/2015; 02032015@99, 8/2/2015; 04012015@25, 9/28/2015; 04272015@55, 10/24/2015

Distribution pattern

Nationwide

drug · product 360 of 382

Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1790-2015
Recall number
D-1790-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
802 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 12182014@66, 6/16/2015; 01052015@51, 7/4/2015; 01192015@33, 7/18/2015; 02192015@9, 8/18/2015; 05042015@38, 10/31/2015; 04012015@63, 9/28/2015

Distribution pattern

Nationwide

drug · product 361 of 382

Tri-Mix MEDIUM (15/0.5/5) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1791-2015
Recall number
D-1791-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
7 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01052015@48, 7/4/2015

Distribution pattern

Nationwide

drug · product 362 of 382

Tri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1792-2015
Recall number
D-1792-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
145 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@15, 8/10/2015 04012015@18 9/28/2015 04272015@52 10/24/2015 05052015@14 11/1/2015

Distribution pattern

Nationwide

drug · product 363 of 382

Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1793-2015
Recall number
D-1793-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
10 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04302015@29, 10/27/2015

Distribution pattern

Nationwide

drug · product 364 of 382

Tri-Mix ST2/LIDO2/PGE2 0.2/0.1/0.04, Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1794-2015
Recall number
D-1794-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
5 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015 04292015@57, 10/26/2015

Distribution pattern

Nationwide

drug · product 365 of 382

Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1795-2015
Recall number
D-1795-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
9 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 03022015@76, 8/29/2015

Distribution pattern

Nationwide

drug · product 366 of 382

Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1796-2015
Recall number
D-1796-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
10 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01272015@29, 7/26/2015

Distribution pattern

Nationwide

drug · product 367 of 382

Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1797-2015
Recall number
D-1797-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01272015@28, 7/26/2015

Distribution pattern

Nationwide

drug · product 368 of 382

Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1798-2015
Recall number
D-1798-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
112 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015

Distribution pattern

Nationwide

drug · product 369 of 382

Tri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1799-2015
Recall number
D-1799-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
112 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@19, 8/10/2015; 02032015@77, 8/2/2015; 04012015@19, 9/28/2015; 04272015@54, 10/24/2015

Distribution pattern

Nationwide

drug · product 370 of 382

Tri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1800-2015
Recall number
D-1800-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
101 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@22, 8/10/2015; 02032015@87, 8/2/2015; 05062015@3, 11/2/2015; 04272015@53, 10/24/2015

Distribution pattern

Nationwide

drug · product 371 of 382

Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1801-2015
Recall number
D-1801-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
79 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@24, 8/10/2015; 02032015@101, 8/2/2015, 04012015@21, 9/28/2015

Distribution pattern

Nationwide

drug · product 372 of 382

Tri-Mix SUPER (28 mg/0.9 mg/37 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1802-2015
Recall number
D-1802-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
161 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01202015@30, 7/19/2015; 01262015@22, 7/25/2015; 02092015@14, 7/1/2015; 02192015@12, 8/18/2015; 03202015@86, 9/16/2015; 03232015@25, 9/19/2015; 04282015@14, 10/25/2015; 04282015@18, 10/25/2015

Distribution pattern

Nationwide

drug · product 373 of 382

Tri-Mix T-101 (17.65 mg/0.59 mg/5.9 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1803-2015
Recall number
D-1803-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
223 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02112015@9, 8/10/2015; 02032015@25, 8/2/2015; 04012015@14, 9/28/2015; 05052015@10, 11/1/2015; 04272015@43, 10/24/2015

Distribution pattern

Nationwide

drug · product 374 of 382

Tri-Mix T-102 (17.65 mg/0.59 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1804-2015
Recall number
D-1804-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
5 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05052015@20, 11/3/2015

Distribution pattern

Nationwide

drug · product 375 of 382

Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1805-2015
Recall number
D-1805-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
19 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05062015@38, 11/2/2015

Distribution pattern

Nationwide

drug · product 376 of 382

Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1806-2015
Recall number
D-1806-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
222 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 05052015@11, 11/1/2015; 02112015@11, 8/10/2015; 02032015@28, 8/2/2015; 04012015@16, 9/26/2015; 04272015@47, 10/24/2015

Distribution pattern

Nationwide

drug · product 377 of 382

Tri-Mix T-106 (30 mg/1 mg/25 mcg) Injectable,The Compounding Pharmacy of America, Knoxville, TN

D-1807-2015
Recall number
D-1807-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
300 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 02032015@57, 8/2/2015; 02112015@14, 8/10/2015; 04012015@17, 9/28/2015; 04272015@49, 10/24/2015; 05052015@12, 11/1/2015

Distribution pattern

Nationwide

drug · product 378 of 382

Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1808-2015
Recall number
D-1808-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
4 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04172015@7, 10/14/2015

Distribution pattern

Nationwide

drug · product 379 of 382

Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1809-2015
Recall number
D-1809-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
68 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04012015@23, 9/28/2015; 04272015@41, 10/24/2015; 05052015@9, 11/1/2015

Distribution pattern

Nationwide

drug · product 380 of 382

Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1810-2015
Recall number
D-1810-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
8 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 001072015@39, 7/6/2015

Distribution pattern

Nationwide

drug · product 381 of 382

Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1811-2015
Recall number
D-1811-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
5 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 01152015@46, 7/14/2015

Distribution pattern

Nationwide

drug · product 382 of 382

Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1812-2015
Recall number
D-1812-2015
Initiated
June 02, 2015
Classification
Class II
Status
Terminated
Quantity
7 ml

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP violations
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information

All lots distributed between November 2014 and May 2015; 04282015@33, 10/25/2015

Distribution pattern

Nationwide