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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69519

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

Open FDA event record

Event summary

Timeline bucket
October 06, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Oregon Compounding Centers, Inc. dba Creative Compounds

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

56 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 56

ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.

D-0173-2015
Recall number
D-0173-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
5 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140913@10, discard date 10/28/2014

Distribution pattern

Oregon, Washington

drug · product 2 of 56

ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.

D-0174-2015
Recall number
D-0174-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
5 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140902@17/1.25; discard date: 10/17/2014

Distribution pattern

Oregon, Washington

drug · product 3 of 56

ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.

D-0175-2015
Recall number
D-0175-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
2500 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140821@17, discard date:10/20/2014

Distribution pattern

Oregon, Washington

drug · product 4 of 56

ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.

D-0176-2015
Recall number
D-0176-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
7900 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140827@34, discard date: 10/26/2014; Lot #: 20140909@22, discard dae: 11/8/2014; Lot #: 20140912@2, discard date: 11/11/2014.

Distribution pattern

Oregon, Washington

drug · product 5 of 56

AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.

D-0177-2015
Recall number
D-0177-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
5483/0.5 mL syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140715@13, discard date: 11/3/2014; Lot #: 20140716@25, discard date: 10/14/2014; Lot #: 20140717@7, discard date: 10/15/2014; Lot #: 20140724@14, discard date: 10/22/2014; Lot #: 20140724@15, discard date: 10/22/2014; Lot #: 20140729@11, discard date: 10/27/2014; Lot #: 20140801@17, discard date: 10/30/2014; Lot #: 20140805@1, discard date: 11/3/2014; Lot #: 20140807@13, discard date: 11/5/2014; Lot #: 20140811@30, discard date: 11/9/2014; Lot #: 20140813@10, discard date: 11/11/2014; Lot #: 20140825@8, discard date: 11/23/2014; Lot #: 20140904@46, discard date: 12/3/2014; Lot #: 20140909@12, discard date: 12/8/2014; Lot #: 20140909@21, discard date: 12/8/2014; Lot #: 20140912@30, discard date: 12/11/2014; Lot #: 20140917@11, discard date: 12/16/2014; Lot #: 20140917@9, discard date: 12/16/2014; Lot #: 20140922@30, discard date: 12/21/2014; Lot #: 20140814@15, discard date: 11/12/2014.

Distribution pattern

Oregon, Washington

drug · product 6 of 56

BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.

D-0178-2015
Recall number
D-0178-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
2.65 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140916@3, discard date: 12/15/2014.

Distribution pattern

Oregon, Washington

drug · product 7 of 56

CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0179-2015
Recall number
D-0179-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
580 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140815@47, discard date: 1/28/2015

Distribution pattern

Oregon, Washington

drug · product 8 of 56

CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

D-0180-2015
Recall number
D-0180-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
12 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140905@33, discard date: 10/20/2014

Distribution pattern

Oregon, Washington

drug · product 9 of 56

CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0181-2015
Recall number
D-0181-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
145 vials

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140728@55, discard date: 1/14/2015; Lot #: 20140915@14, discard date: 3/8/2015.

Distribution pattern

Oregon, Washington

drug · product 10 of 56

CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0182-2015
Recall number
D-0182-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
117 vials

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140909@5, discard date: 3/8/2015; Lot #: 20140728@57, discard date: 1/14/2015.

Distribution pattern

Oregon, Washington

drug · product 11 of 56

CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

D-0183-2015
Recall number
D-0183-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
900 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140908@2, discard date: 10/23/2014

Distribution pattern

Oregon, Washington

drug · product 12 of 56

COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0184-2015
Recall number
D-0184-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
600 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140919@21, discard date: 11/3/2014

Distribution pattern

Oregon, Washington

drug · product 13 of 56

DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0185-2015
Recall number
D-0185-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
4 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140903@10, discard date: 10/18/2014

Distribution pattern

Oregon, Washington

drug · product 14 of 56

DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0186-2015
Recall number
D-0186-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
210 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140828@14; discard date: 11/26/2014

Distribution pattern

Oregon, Washington

drug · product 15 of 56

DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0187-2015
Recall number
D-0187-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
280 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140724@24/5, discard date: 10/22/2014; Lot #: 20140724@25, discard date: 10/22/2014; Lot #: 20140826@12, discard date: 11/24/2014.

Distribution pattern

Oregon, Washington

drug · product 16 of 56

EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0188-2015
Recall number
D-0188-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
10 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140913@2, discard date: 10/18/2014

Distribution pattern

Oregon, Washington

drug · product 17 of 56

ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0189-2015
Recall number
D-0189-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
4 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140828@15, discard date: 10/12/2014

Distribution pattern

Oregon, Washington

drug · product 18 of 56

GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

D-0190-2015
Recall number
D-0190-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
40 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140916@16, discard date: 10/31/2014

Distribution pattern

Oregon, Washington

drug · product 19 of 56

GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

D-0191-2015
Recall number
D-0191-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
20 Syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140911@9, discard date: 10/26/2014

Distribution pattern

Oregon, Washington

drug · product 20 of 56

GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070

D-0192-2015
Recall number
D-0192-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
800 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140917@27, discard date: 10/22/2014

Distribution pattern

Oregon, Washington

drug · product 21 of 56

GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070

D-0193-2015
Recall number
D-0193-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
300 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140912@29/150, discard date: 10/16/2014

Distribution pattern

Oregon, Washington

drug · product 22 of 56

GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070

D-0194-2015
Recall number
D-0194-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
250 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140722@5, discard date: 10/20/2014; Lot #: 20140723@45, discard date: 10/21/2014.

Distribution pattern

Oregon, Washington

drug · product 23 of 56

GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0195-2015
Recall number
D-0195-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
2200 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140721@25/00, discard date: 11/18/2014; Lot #: 20140902@47, discard date: 12/31/2014.

Distribution pattern

Oregon, Washington

drug · product 24 of 56

GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0196-2015
Recall number
D-0196-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
900 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140718@4, discard date: 10/16/2014

Distribution pattern

Oregon, Washington

drug · product 25 of 56

HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0197-2015
Recall number
D-0197-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
10 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140818@27, discard date: 2/21/2015

Distribution pattern

Oregon, Washington

drug · product 26 of 56

HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0198-2015
Recall number
D-0198-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
58 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140717@6, discard date: 10/15/2014

Distribution pattern

Oregon, Washington

drug · product 27 of 56

HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0199-2015
Recall number
D-0199-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
570 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140729@18, discard date: 10/27/2014

Distribution pattern

Oregon, Washington

drug · product 28 of 56

HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0200-2015
Recall number
D-0200-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
520 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140718@1/5, discard date: 1/14/2015; Lot #: 20140813@25, discard date: 2/9/2015; Lot #: 20140903@32, discard date: 3/2/2015.

Distribution pattern

Oregon, Washington

drug · product 29 of 56

LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070

D-0201-2015
Recall number
D-0201-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140815@12, discard date: 2/16/2015

Distribution pattern

Oregon, Washington

drug · product 30 of 56

METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0202-2015
Recall number
D-0202-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
120 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140729@16/1, discard date: 11/26/2014

Distribution pattern

Oregon, Washington

drug · product 31 of 56

METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0203-2015
Recall number
D-0203-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
516 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140722@2/2, discard date: 1/18/2015; Lot #: 20140910@40/2, discard date: 3/9/2015.

Distribution pattern

Oregon, Washington

drug · product 32 of 56

METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0204-2015
Recall number
D-0204-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
119/0.3 mL vials and 106/1 mL vials

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140718@2/0.3, discard date: 1/14/2015; Lot #: 20140808@4/0.3, discard date: 2/4/2015; Lot #: 20140902@36/1, discard date: 3/1/2015; Lot #: 20140902@37/0.3, discard date: 3/1/2015; Lot #: 20140912@22/1, discard date: 3/11/2015.

Distribution pattern

Oregon, Washington

drug · product 33 of 56

METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0205-2015
Recall number
D-0205-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
1320 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140715@2, discard date: 10/13/2014; Lot #: 20140724@10, discard date: 10/22/2014; Lot #: 20140812@14, discard date: 11/1/2014; Lot #: 20140826@5, discard date: 11/1/2014;

Distribution pattern

Oregon, Washington

drug · product 34 of 56

MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0206-2015
Recall number
D-0206-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
5 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140913@1, discard date: 10/28/2014

Distribution pattern

Oregon, Washington

drug · product 35 of 56

MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0207-2015
Recall number
D-0207-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
8 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140913@4, discard date: 10/28/2014

Distribution pattern

Oregon, Washington

drug · product 36 of 56

OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0208-2015
Recall number
D-0208-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
680 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140711@1, discard date: 1/7/2015; Lot #: 20140814@22, discard date: 2/10/2015; Lot #: 20140815@13, discard date: 2/11/2015.

Distribution pattern

Oregon, Washington

drug · product 37 of 56

PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0209-2015
Recall number
D-0209-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
25 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140827@30, discard date: 10/11/2014; Lot #: 20140910@28/1.7, discard date: 10/25/2014; Lot #: 20140917@2/1.25, discard date: 11/1/2014.

Distribution pattern

Oregon, Washington

drug · product 38 of 56

PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0210-2015
Recall number
D-0210-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
43 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140722@16/1.7, discard date: 12/3/2014; Lot #: 20140728@43/2, discard date: 12/3/2014.

Distribution pattern

Oregon, Washington

drug · product 39 of 56

PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0211-2015
Recall number
D-0211-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
5 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140903@14/1.25, discard date: 10/18/2014

Distribution pattern

Oregon, Washington

drug · product 40 of 56

PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0212-2015
Recall number
D-0212-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
10 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140901@3, discard date: 10/19/2014

Distribution pattern

Oregon, Washington

drug · product 41 of 56

PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0213-2015
Recall number
D-0213-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
46.7 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140708@30, discard date: 12/2/2014

Distribution pattern

Oregon, Washington

drug · product 42 of 56

PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0214-2015
Recall number
D-0214-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
5 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140912@25, discard date: 10/27/2014

Distribution pattern

Oregon, Washington

drug · product 43 of 56

PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0215-2015
Recall number
D-0215-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
15 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140910@48/1.25, discard date: 10/25/2014; Lot #: 20140911@11/1.25, discard date: 10/26/2014; Lot #: 20140916@17/1.25, discard date: 10/31/2014.

Distribution pattern

Oregon, Washington

drug · product 44 of 56

PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0216-2015
Recall number
D-0216-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
103.4 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection..

Code information

Lot #: 20140728@39, discard date: 12/3/2014;

Distribution pattern

Oregon, Washington

drug · product 45 of 56

PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0217-2015
Recall number
D-0217-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
10 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140910@42, discard date: 1/25/2015

Distribution pattern

Oregon, Washington

drug · product 46 of 56

PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0218-2015
Recall number
D-0218-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
1.7 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140828@4/1.7, discard date: 10/15/2014

Distribution pattern

Oregon, Washington

drug · product 47 of 56

PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070

D-0219-2015
Recall number
D-0219-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
10 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140902@22, discard date: 10/17/2014

Distribution pattern

Oregon, Washington

drug · product 48 of 56

PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0220-2015
Recall number
D-0220-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
540 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140905@11/10, discard date: 12/4/2014

Distribution pattern

Oregon, Washington

drug · product 49 of 56

PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0221-2015
Recall number
D-0221-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
660 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140715@18, discard date: 10/13/2014; Lot #: 20140917@18, discard date: 12/16/2014;

Distribution pattern

Oregon, Washington

drug · product 50 of 56

SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0222-2015
Recall number
D-0222-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
180 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140916@23, discard date: 10/31/2014

Distribution pattern

Oregon, Washington

drug · product 51 of 56

TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0223-2015
Recall number
D-0223-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
175 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140812@7, discard date: 2/8/2015; Lot #: 20140910@41, discard date: 3/9/2015;

Distribution pattern

Oregon, Washington

drug · product 52 of 56

TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0224-2015
Recall number
D-0224-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
85 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140714@51, discard date: 1/10/2015

Distribution pattern

Oregon, Washington

drug · product 53 of 56

TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070

D-0225-2015
Recall number
D-0225-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
1000 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection

Code information

Lot #: 20140912@16, discard date: 10/17/2014

Distribution pattern

Oregon, Washington

drug · product 54 of 56

TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

D-0226-2015
Recall number
D-0226-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
2 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140909@6, discard date: 10/24/2014

Distribution pattern

Oregon, Washington

drug · product 55 of 56

VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

D-0227-2015
Recall number
D-0227-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
12 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140905@32, discard date: 10/20/2014

Distribution pattern

Oregon, Washington

drug · product 56 of 56

VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.

D-0228-2015
Recall number
D-0228-2015
Initiated
October 06, 2014
Classification
Class II
Status
Terminated
Quantity
490 mL

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information

Lot #: 20140811@5, discard date 10/16/2014 Lot #: 20140827@12, discard date 11/25/2014

Distribution pattern

Oregon, Washington