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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76912

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

Open FDA event record

Event summary

Timeline bucket
April 18, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Key Pharmacy and Compounding Center

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

79 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 79

5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0707-2017
Recall number
D-0707-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
100 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t11-21-2016@112, Exp 5/21/2017; 12-15-2016@73, Exp 6/13/2017; 01-13-2017@67, Exp 7/12/2017; t02-14-2017@97, Exp 8/14/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 2 of 79

5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0708-2017
Recall number
D-0708-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
6 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t11-17-2016@86, Exp 5/17/2017; t12-22-2016@103, Exp 7/4/2017; t01-09-2017@111, Exp 7/9/2017; t01-11-2017@118, Exp 7/11/2017; t01-18-2017@89, Exp 7/18/2017; t01-20-2017@83, Exp 7/23/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 3 of 79

5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy

D-0709-2017
Recall number
D-0709-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-28-2016@113, Exp 6/27/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 4 of 79

5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

D-0710-2017
Recall number
D-0710-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-05-2016@116, Exp 6/4/2017; t12-15-2016@84, Exp 6/14/2017; t12-23-2016@67, Exp 6/25/2017; t12-28-2016@105, Exp 6/27/2017; t01-30-2017@88, Exp 7/30/2017; t02-06-2017@109, Exp 8/6/2017; t02-14-2017@92, Exp 8/14/2017; t02-20-2017@79, Exp 8/20/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 5 of 79

ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0711-2017
Recall number
D-0711-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
60 mL total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # 01-20-2017@17, Exp 4/20/2017; 01-23-2017@48, Exp 4/23/2017; 01-27-2017@17, Exp 4/27/2017; 01-31-2017@42, Exp 5/1/2017; 02-01-2017@35, Exp 5/2/2017; t02-07-2017@67, Exp 5/9/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 6 of 79

ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0712-2017
Recall number
D-0712-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
9 mL

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-26-2017@93, Exp 4/27/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 7 of 79

CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0713-2017
Recall number
D-0713-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-01-2017@119, Exp 5/3/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 8 of 79

DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy

D-0714-2017
Recall number
D-0714-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
214 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-16-2016@73, Exp 4/18/2017; t12-27-2016@93, Exp 4/27/2017; t01-09-2017@102, Exp 5/10/2017; t01-10-2017@120, Exp 5/11/2017; 02-01-2017@78, Exp 6/1/2017; t02-08-2017@96, Exp 6/9/2017; t02-20-2017@80, Exp 6/21/2017; t02-21-2017@122, Exp 6/23/2017; t02-23-2017@68, Exp 6/24/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 9 of 79

DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy

D-0715-2017
Recall number
D-0715-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
10 mL total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # 02-23-2017@36, Exp 5/24/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 10 of 79

FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0716-2017
Recall number
D-0716-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-23-2017@83, Exp 5/24/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 11 of 79

FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy

D-0717-2017
Recall number
D-0717-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
20 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-20-2017@80, Exp 4/23/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 12 of 79

FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0718-2017
Recall number
D-0718-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
3 vials total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-09-2017@74, Exp 5/15/2017; t02-17-2017@89, Exp 5/21/2017; t02-20-2017@72, Exp 5/22/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 13 of 79

FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy

D-0719-2017
Recall number
D-0719-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
12 vials total (3/2mL vials and 9/10mL vias)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-31-2017@128, Exp 5/2/2017; 01-31-2017@118, Exp 5/1/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 14 of 79

HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0720-2017
Recall number
D-0720-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
72 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # 01-20-2017@74, Exp 4/20/2017; t02-01-2017@123, Exp 5/3/2017; t02-03-2017@47, Exp 5/7/2017; t02-07-2017@70, Exp 5/10/2017; t02-13-2017@100, Exp 5/15/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 15 of 79

HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

D-0721-2017
Recall number
D-0721-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
50 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-16-2017@91, Exp 4/17/2017; t02-08-2017@93, Exp 4/30/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 16 of 79

HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial.

D-0722-2017
Recall number
D-0722-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
50 vials total (10/1mL vials and 40/2mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-17-2017@103, Exp 4/18/2017; t01-23-2017@80, Exp 4/24/2017; t02-10-2017@120, Exp 4/30/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 17 of 79

HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0723-2017
Recall number
D-0723-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
240 mL

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # 02-01-2017@38, Exp 4/30/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 18 of 79

HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.

D-0724-2017
Recall number
D-0724-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
8 vials total (6/10mL vials and 2/30 mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-20-2017@87, Exp 4/23/2017; t02-08-2017@99, Exp 4/30/2017; t02-21-2017@113, Exp 4/30/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 19 of 79

HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy

D-0725-2017
Recall number
D-0725-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
7 vials total (1/5mL vial and 6/30 mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-26-2017@98, Exp 4/27/2017; t02-06-2017@108, Exp 4/30/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 20 of 79

HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0726-2017
Recall number
D-0726-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-06-2017@102, Exp 4/30/2017; t02-16-2017@106, Exp 4/30/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 21 of 79

HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Compounding Pharmacy

D-0727-2017
Recall number
D-0727-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
27 vials total (25/5 mL vials and 2/30mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-16-2017@93, Exp 4/17/2017; t01-20-2017@81, Exp 4/23/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 22 of 79

HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0728-2017
Recall number
D-0728-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-15-2017@111, Exp 4/30/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 23 of 79

PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0729-2017
Recall number
D-0729-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
4 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t11-28-2016@111, Exp 5/28/2017; 02-10-2017@1, Exp 8/9/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 24 of 79

PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0730-2017
Recall number
D-0730-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
4 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-21-2016@110, Exp 6/20/2017; t12-27-2016@84, Exp 6/26/2017; t12-30-2016@74, Exp 7/2/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 25 of 79

PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy

D-0731-2017
Recall number
D-0731-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
5 vials total (2/5 mL vials, 1/10mL vial, and 2/15mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-05-2017@102, Exp 7/5/2017; t02-02-2017@105, Exp 8/2/2017; t02-10-2017@121, Exp 8/2/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 26 of 79

PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0732-2017
Recall number
D-0732-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-06-2017@92, Exp 7/5/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 27 of 79

PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0733-2017
Recall number
D-0733-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-25-2017@112, Exp 7/5/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 28 of 79

PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0734-2017
Recall number
D-0734-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t11-16-2016@90, Exp 4/19/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 29 of 79

TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0735-2017
Recall number
D-0735-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-22-2016@102, Exp 6/18/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 30 of 79

TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0736-2017
Recall number
D-0736-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-19-2016@69, Exp 5/22/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 31 of 79

TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0737-2017
Recall number
D-0737-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
200 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # 11-18-2016@70, Exp 4/19/2017; 11-23-2016@84, Exp 5/22/2017; t12-14-2016@99, Exp 5/22/2017; t01-03-2017@94, Exp 6/18/2017; 01-13-2017@71, Exp 7/5/2017; 01-25-2017@103, Exp 7/5/2017; 02-06-2017@94, Exp 7/5/2017; t02-17-2017@87, Exp 8/2/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 32 of 79

TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0738-2017
Recall number
D-0738-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
6 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t11-21-2016@125, Exp 4/19/2017; t01-09-2017@105, Exp 6/18/2017; t01-18-2017@90, Exp 7/5/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 33 of 79

TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0739-2017
Recall number
D-0739-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-12-2016@84, Exp 5/22/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 34 of 79

TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0740-2017
Recall number
D-0740-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-31-2017@127, Exp 7/5/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 35 of 79

TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0741-2017
Recall number
D-0741-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-31-2017@120, Exp 7/5/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 36 of 79

TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0742-2017
Recall number
D-0742-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
25 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-10-2017@115, Exp 7/5/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 37 of 79

TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0743-2017
Recall number
D-0743-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t11-23-2016@110, Exp 5/22/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 38 of 79

TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0744-2017
Recall number
D-0744-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-01-2016@93, Exp 5/22/2017; t02-02-2017@100, Exp 8/2/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 39 of 79

TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial , Prepared by Key Compounding Pharmacy

D-0745-2017
Recall number
D-0745-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
17 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-07-2016@97, Exp 5/22/2017; t12-12-2016@88, Exp 5/22/2017; t12-20-2016@109, Exp 5/22/2017; t12-20-2016@119, Exp 6/18/2017; t12-23-2016@63, Exp 6/18/2017; t12-30-2016@84, Exp 6/18/2017; t01-09-2017@97, Exp 6/18/2017; t12-22-2016@120, Exp 6/18/2017; t02-07-2017@72, Exp 8/2/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 40 of 79

TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0746-2017
Recall number
D-0746-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-13-2016@95, Exp 5/22/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 41 of 79

TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0747-2017
Recall number
D-0747-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-02-2017@93, Exp 8/2/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 42 of 79

TRI MIX 40/30/4 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0748-2017
Recall number
D-0748-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
5 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-30-2016@73, Exp 6/18/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 43 of 79

TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0749-2017
Recall number
D-0749-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-12-2016@87, Exp 5/22/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 44 of 79

TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0750-2017
Recall number
D-0750-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-02-2016@100, Exp 5/22/2017; t12-28-2016@104, Exp 6/18/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 45 of 79

TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0751-2017
Recall number
D-0751-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
4 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-12-2016@93, Exp 5/22/2017; t02-22-2017@93, Exp 8/2/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 46 of 79

TRI MIX 5/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 5mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0752-2017
Recall number
D-0752-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-01-2017@127, Exp 7/5/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 47 of 79

TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0753-2017
Recall number
D-0753-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-13-2016@98, Exp 5/22/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 48 of 79

QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0754-2017
Recall number
D-0754-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-05-2017@110, Exp 6/17/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 49 of 79

QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0755-2017
Recall number
D-0755-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-02-2017@102, Exp 7/26/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 50 of 79

PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0756-2017
Recall number
D-0756-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-12-2016@92, Exp 5/22/2017; t02-14-2017@103, Exp 8/2/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 51 of 79

PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0757-2017
Recall number
D-0757-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
4 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t11-28-2016@86, Exp 5/22/2017; t12-19-2016@73, Exp 5/22/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 52 of 79

ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0758-2017
Recall number
D-0758-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-22-2017@96, Exp 5/24/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 53 of 79

VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy

D-0759-2017
Recall number
D-0759-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
10 mL

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # 02-23-2017@35, Exp 4/24/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 54 of 79

CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0760-2017
Recall number
D-0760-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-06-2017@107, Exp 4/30/2017 Lot t02-06-2017@107, Expiry date 4/30/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 55 of 79

CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0761-2017
Recall number
D-0761-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-13-2017@99, Exp 5/15/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 56 of 79

FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0763-2017
Recall number
D-0763-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
3 vials total (2/5mL vials and 1/10mL)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-13-2017@98, Exp 5/15/2017; t02-14-2017@98, Exp 5/16/2017; t02-15-2017@120, Exp 5/17/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 57 of 79

IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0764-2017
Recall number
D-0764-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-16-2017@108, Exp 5/18/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 58 of 79

GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0765-2017
Recall number
D-0765-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
240 mL

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # 02-20-2017@8, Exp 4/21/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 59 of 79

GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compounding Pharmacy

D-0766-2017
Recall number
D-0766-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
50 mL

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-20-2017@75, Exp 4/22/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 60 of 79

GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0767-2017
Recall number
D-0767-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
180mL

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-21-2017@111, Exp 4/23/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 61 of 79

MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0768-2017
Recall number
D-0768-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-06-2017@106, Exp 5/8/2017; 02-13-2017@75, Exp 5/14/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 62 of 79

METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0769-2017
Recall number
D-0769-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
26 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-17-2017@101, Exp 4/21/2017; t02-17-2017@88, Exp 4/21/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 63 of 79

METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0770-2017
Recall number
D-0770-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
25 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-17-2017@86, Exp 4/21/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 64 of 79

PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1%, Rx only, 50mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0771-2017
Recall number
D-0771-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-18-2017@94, Exp 4/19/2017; t01-25-2017@115, Exp 4/26/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 65 of 79

PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

D-0772-2017
Recall number
D-0772-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
40 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-13-2017@84, Exp 4/18/2017; 02-02-2017@97, Exp 5/3/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 66 of 79

PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

D-0773-2017
Recall number
D-0773-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
86 vials total (78/5mL vials and 8/50mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t11-21-2016@115, Exp 5/21/2017; t11-23-2016@109, Exp 5/27/2017; t12-13-2016@94, Exp 6/12/2017; t01-19-2017@85, Exp 7/22/2017; 02/01/2017@116, Exp 7/31/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 67 of 79

PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

D-0774-2017
Recall number
D-0774-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
9 vials total (3/10mL vials and 6/50mL vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-25-2017@122, Exp 4/26/2017; t12-12-2016@98, Exp 6/11/2017; t01-10-2017@119, Exp 7/10/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 68 of 79

PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass; Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0775-2017
Recall number
D-0775-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot t# 02-14-2017@102, Exp 5/1/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 69 of 79

PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0776-2017
Recall number
D-0776-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-31-2017@132, Exp 5/2/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 70 of 79

PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0777-2017
Recall number
D-0777-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-20-2017@74, Exp 5/22/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 71 of 79

SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Pharmacy

D-0778-2017
Recall number
D-0778-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-26-2017@94, Exp 4/27/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 72 of 79

SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0779-2017
Recall number
D-0779-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
30 mL

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-17-2017@85, Exp 5/21/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 73 of 79

SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

D-0780-2017
Recall number
D-0780-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
75 mL

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # 11-29-2016@27, Exp 5/20/2017; 01-25-2017@25, Exp 7/24/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 74 of 79

SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

D-0781-2017
Recall number
D-0781-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
91 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t12-19-2016@76, Exp 4/27/2017; t11-28-2016@114, Exp 5/28/2017; t11-29-2016@102, Exp 5/29/2017; t12-06-2016@98, Exp 6/6/2017; t12-22-2016@118, Exp 6/21/2017; t12-22-2016@119, Exp 6/21/2017; t02-06-2017@98, Exp 8/6/2017; t02-07-2017@60, Exp 8/7/2017; t02-21-2017@109, Exp 08/21/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 75 of 79

TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0782-2017
Recall number
D-0782-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-16-2017@9, Exp 4/17/2017; t01-19-2017@89, Exp 4/20/2017.

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 76 of 79

TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

D-0783-2017
Recall number
D-0783-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
6 vials total (5/5mL vials and 1/10mL vial)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-09-2017@79, Exp 5/14/2017; t02-22-2017@91, Exp 5/24/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 77 of 79

VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy

D-0784-2017
Recall number
D-0784-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-03-2017@37, Exp 5/7/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 78 of 79

VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

D-0785-2017
Recall number
D-0785-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
6/1mL vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t02-10-2017@122, Exp 5/14/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.

drug · product 79 of 79

VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

D-0786-2017
Recall number
D-0786-2017
Initiated
April 18, 2017
Classification
Class II
Status
Terminated
Quantity
5/2 mL vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Code information

Lot # t01-31-2017@119, Exp 5/2/2017; t02-01-2017@130, Exp 5/4/2017

Distribution pattern

Distributed nationwide in U.S.A., Australia and Canada.