Wilsonville, Ore. – Oregon Compounding Centers, Inc., dba Creative Compounds, is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assurance.
The company has not received any reports of product contamination or adverse events to date, but is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
“We are fully cooperating with health officials,” said Denise Burnham, R.Ph., owner and pharmacist. “We deeply regret the impact this voluntary recall has on our customers, but patient safety is our highest priority.”
All recalled products have a label that includes the Creative Compounds name as well as a lot number. The recalled products were made from July 1, 2014 through September 22, 2014, and distributed to health care facilities, physicians, and patients in two states, Oregon and Washington.
The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy.
All unexpired lots of the following sterile compounded products are subject to the recall:
|
Human Products |
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|
Medication |
Lot Number |
Discard Date |
|
ALPROSTADIL 10 MCG/ML INJECTABLE |
20140913@10 |
10/28/2014 |
|
ALPROSTADIL/LIDOCAINE HCL |
20140902@17/1.25 |
10/17/2014 |
|
ASCORBIC ACID (B) 500 MG/ML INJECTABLE |
20140821@17 |
10/20/2014 |
|
ASCORBIC ACID (PRES) 500 MG/ML |
20140827@34 |
10/26/2014 |
|
|
20140909@22 |
11/8/2014 |
|
|
20140912@2 |
11/11/2014 |
|
AVASTIN (SYRINGE-REPKG) 1.25MG/0.5ML |
20140715@13 |
11/3/2014 |
|
|
20140716@25 |
10/14/2014 |
|
|
20140717@7 |
10/15/2014 |
|
|
20140724@14 |
10/22/2014 |
|
|
20140724@15 |
10/22/2014 |
|
|
20140729@11 |
10/27/2014 |
|
|
20140801@17 |
10/30/2014 |
|
|
20140805@1 |
11/3/2014 |
|
|
20140807@13 |
11/5/2014 |
|
|
20140811@30 |
11/9/2014 |
|
|
20140813@10 |
11/11/2014 |
|
|
20140825@8 |
11/23/2014 |
|
|
20140904@46 |
12/3/2014 |
|
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20140905@8 |
12/4/2014 |
|
|
20140909@12 |
12/8/2014 |
|
|
20140909@21 |
12/8/2014 |
|
|
20140912@30 |
12/11/2014 |
|
|
20140917@11 |
12/16/2014 |
|
|
20140917@9 |
12/16/2014 |
|
|
20140922@30 |
12/21/2014 |
|
|
20140814@15 |
11/12/2014 |
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BEVACIZUMAB/DEXAMETHASONE (SYRINGE) |
20140916@3 |
12/15/2014 |
|
CALCIUM CHLORIDE (COMPOUND) 100 MG/ML |
20140815@47 |
1/28/2015 |
|
CEFTAZIDIME (SYRINGE) 2.25/0.1ML |
20140905@33 |
10/20/2014 |
|
CHORIONIC GONADTROPIN (STERILE) 4000 |
20140728@55 |
1/14/2015 |
|
|
20140915@14 |
3/8/2015 |
|
CHORIONIC GONADOTROPIN (STERILE) 5000 |
20140909@5 |
3/8/2015 |
|
|
20140728@57 |
1/14/2015 |
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CITRIC ACID/GLUCONOLACTONE MAGNES |
20140908@2 |
10/23/2014 |
|
COPPER (SULF) 0.4 MG/ML INJECTABLE |
20140919@21 |
11/3/2014 |
|
DEXAMETHASONE (AS SOD PHOS) 24 MG/ML |
20140903@10 |
10/18/2014 |
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DEXPANTHENOL – (PRES) 250 MG/ML |
20140828@14 |
11/26/2014 |
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DMPS-PRES FREE 50 MG/ML INJECTABLE |
20140724@24/5 |
10/22/2014 |
|
|
20140724@25 |
10/22/2014 |
|
|
20140826@12 |
11/24/2014 |
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EPINEPHRINE/WATER (PF) 1:1000 INJECTABLE |
20140913@2 |
10/18/2014 |
|
ESTRADIOL CYPIONATE |
20140828@15 |
10/12/2014 |
|
GANCICLOVIR (PF) 2MG/0.1ML INJECTABLE |
20140916@16 |
10/31/2014 |
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GANCICLOVIR (PF) 0.2MG/0.1ML INJECTABLE |
20140911@9 |
10/26/2014 |
|
GENTAMICIN SULFATE 100MG/1000ML |
20140917@27 |
10/22/2014 |
|
GENTAMICIN SULFATE 480MG/1000ML IRRIG |
20140912@29 |
10/16/2014 |
|
GLUTARALDEHYDE BUFFERED (POTASSIUM |
20140722@5 |
10/20/2014 |
|
|
20140723@45 |
10/21/2014 |
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GLUTATHIONE (PRES) 100MG/ML INJECTABLE |
20140721@25/00 |
11/18/2014 |
|
|
20140902@47 |
12/31/2014 |
|
GLUTATHIONE 100 MG/ML INJECTABLE |
20140718@4 |
10/16/2014 |
|
HYALURONIDASE 240U/ML INJECTABLE |
20140818@27 |
2/21/2015 |
|
HYDROXOCOBALAMIN-PF (B12) 1MG/ML INJ |
20140717@6 |
10/15/2014 |
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HYDROXOCOBALAMIN-PRES (B12) 1MG/ML INJ |
20140729@18 |
10/27/2014 |
|
HYDROXYPROGESTERONE CAPROATE |
20140718@1/5 |
1/14/2015 |
|
|
20140813@25 |
2/9/2015 |
|
|
20140903@32 |
3/2/2015 |
|
LIDOCAINE HCL (REPKG-STERILE) 4% |
20140815@12 |
2/16/2015 |
|
METHYCOBALAMIN (PF) 10MG/ML |
20140729@16/1 |
11/26/2014 |
|
METHYCOBALAMIN (PF) 1MG/ML INJECTABLE |
20140722@2/2 |
1/18/2015 |
|
|
20140910@40/2 |
3/9/2015 |
|
METHYCOBALAMIN (PF) 20MG/ML |
20140718@2/0.3 |
1/14/2015 |
|
|
20140808@4/0.3 |
2/4/2015 |
|
|
20140902@36/1 |
3/1/2015 |
|
|
20140902@37/0.3 |
3/1/2015 |
|
|
20140912@22 |
3/11/2015 |
|
METHYCOBALAMIN (PRES) 1MG/ML |
20140715@2 |
10/13/2014 |
|
|
20140724@10 |
10/22/2014 |
|
|
20140812@14 |
11/1/2014 |
|
|
20140826@5 |
11/1/2014 |
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MITOMYCIN 0.2MG/ML INJECTABLE |
20140913@1 |
10/28/2014 |
|
MITOMYCIN 0.3MG/ML INJECTABLE |
20140913@4 |
10/28/2014 |
|
OMNIPAQUE (REPKG) 300MGI/ML INJECTABLE |
20140711@1 |
1/7/2015 |
|
|
20140814@22 |
2/10/2015 |
|
|
20140815@13 |
2/11/2015 |
|
PAPAV HCL/PHENTOL/PROSTAGL 12/1/10 |
20140827@30 |
10/11/2014 |
|
|
20140910@28 |
10/25/2014 |
|
|
20140917@2/1.25 |
11/1/2014 |
|
PAPAVERINE |
20140722@16/1.7 |
12/3/2014 |
|
|
20140728@43/2 |
12/3/2014 |
|
PAPAVERINE HCL (PRES) 30 MG/ML |
20140903@14/1.25 |
10/18/2014 |
|
PAPAVERINE HCL/PHENTOLAMINE |
20140901@3 |
10/19/2014 |
|
PAPAVERINE HCL/PHENTOLAMINE |
20140708@30 |
12/2/2014 |
|
PAPAVERINE |
20140912@25 |
10/27/2014 |
|
PAPAVERINE/PHENTOLAMINE/ALPROSTADIL |
20140910@48/1.25 |
10/25/2014 |
|
|
20140911@11/1.25 |
10/26/2014 |
|
|
20140916@17/1.25 |
10/31/2014 |
|
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN 17.16/0.57/19.45 INJ |
20140728@39 |
12/3/2014 |
|
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN 17.44/0.64/5.8 INJ |
20140910@42 |
1/25/2015 |
|
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN 17.64/0.58/5.88 INJ |
20140828@4/1.7 |
10/15/2014 |
|
PREDNISOLONE SOD PHOS 1% OPTHAMALIC |
20140902@22 |
10/17/2014 |
|
PROCAINE HCL (BUFF) 1% INJECTABLE |
20140905@11 |
12/4/2014 |
|
PYRIDOXINE HCL (PRES)100 MG/ML |
20140715@18 |
10/13/2014 |
|
|
20140917@18 |
12/16/2014 |
|
SODIUM CHLORIDE INHALATION 7% |
20140916@23 |
10/31/2014 |
|
TESTOSTERONE CYPIONATE (GRAPE SEED |
20140812@7 |
2/8/2015 |
|
|
20140910@41 |
3/9/2015 |
|
TESTOSTERONE CYPIONATE (SESAME |
20140714@51 |
1/10/2015 |
|
TOBRAMYCIN 480MG/1000 ML IRRIG |
20140912@16 |
10/17/2014 |
|
TRIESENCE (SYRINGE-REPKG) 8MG/2.0ML INJ |
20140909@6 |
10/24/2014 |
|
VANCOMYCIN (SYRINGE) 1MG/0.1ML INJ |
20140905@32 |
10/20/2014 |
|
VITAMIN B COMPLEX(PRES) 100 INJ |
20140811@5 |
10/16/2014 |
|
|
20140827@12 |
11/25/2014 |
|
Veterinary Products |
||
|
Medication |
Lot Number |
Discard Date |
|
APOMORPHINE HCL 3MG/ML INJECTABLE |
20140818@37 |
11/16/2014 |
|
CYCLOSPORINE-E PLUS 2% OPHTHALMIC |
20140702@12 |
12/29/2014 |
|
POLYSULF GLUCOSAMIN GLYCAN 10% |
20140820@7/30 |
11/18/2014 |
The company has begun notifying its customers by telephone, fax, electronic mail and/or regular mail of this recall. Users or recipients of these products should immediately discontinue use and return the recalled unexpired products. To return product or request assistance related to this recall, users should call 503-685-6111 or 877-585-6111, Monday through Friday, from 9:30 a.m. to 1 p.m. and 1:30 to 5:30 p.m. PDT.
Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking these drug products. Adverse reactions experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax
- Online: Complete and submit a report at www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and mail to address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.