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Recall -- Firm Press Release

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Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington Due to Lack of Sterility Assurance

Contact
Consumer:
877-585-6111
 

FOR IMMEDIATE RELEASE - October 9, 2014 - 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
MedicationLot NumberDiscard Date
ALPROSTADIL 10 MCG/ML INJECTABLE20140913@1010/28/2014
ALPROSTADIL/LIDOCAINE HCL 20MCG/5MG/ML20140902@17/1.2510/17/2014
ASCORBIC ACID (B) 500 MG/ML INJECTABLE20140821@1710/20/2014
ASCORBIC ACID (PRES) 500 MG/ML INJECTABLE20140827@3410/26/2014
 20140909@2211/8/2014
 20140912@211/11/2014
AVASTIN (SYRINGE-REPKG) 1.25MG/0.5ML INJECTABLE20140715@1311/3/2014
 20140716@2510/14/2014
 20140717@710/15/2014
 20140724@1410/22/2014
 20140724@1510/22/2014
 20140729@1110/27/2014
 20140801@1710/30/2014
 20140805@111/3/2014
 20140807@1311/5/2014
 20140811@3011/9/2014
 20140813@1011/11/2014
 20140825@811/23/2014
 20140904@4612/3/2014
 20140905@812/4/2014
 20140909@1212/8/2014
 20140909@2112/8/2014
 20140912@3012/11/2014
 20140917@1112/16/2014
 20140917@912/16/2014
 20140922@3012/21/2014
 20140814@1511/12/2014
BEVACIZUMAB/DEXAMETHASONE (SYRINGE) 1.25/0.5 ML INJECTABLE20140916@312/15/2014
CALCIUM CHLORIDE (COMPOUND) 100 MG/ML INJECTABLE20140815@471/28/2015
CEFTAZIDIME (SYRINGE) 2.25/0.1ML INJECTABLE20140905@3310/20/2014
CHORIONIC GONADTROPIN (STERILE) 4000 UNITS POWDER20140728@551/14/2015
 20140915@143/8/2015
CHORIONIC GONADOTROPIN (STERILE) 5000 UNITS POWDER20140909@53/8/2015
 20140728@571/14/2015
CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN) 66/1.98/31.77 MG/ML20140908@210/23/2014
COPPER (SULF) 0.4 MG/ML INJECTABLE20140919@2111/3/2014
DEXAMETHASONE (AS SOD PHOS) 24 MG/ML INJECTABLE20140903@1010/18/2014
DEXPANTHENOL - (PRES) 250 MG/ML INJECTABLE20140828@1411/26/2014
DMPS-PRES FREE 50 MG/ML INJECTABLE20140724@24/510/22/2014
 20140724@2510/22/2014
 20140826@1211/24/2014
EPINEPHRINE/WATER (PF) 1:1000 INJECTABLE20140913@210/18/2014
ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL) 5 MG/ML INJECTABLE20140828@1510/12/2014
GANCICLOVIR (PF) 2MG/0.1ML INJECTABLE20140916@1610/31/2014
GANCICLOVIR (PF) 0.2MG/0.1ML INJECTABLE20140911@910/26/2014
GENTAMICIN SULFATE 100MG/1000ML IRRIGATION20140917@2710/22/2014
GENTAMICIN SULFATE 480MG/1000ML IRRIG20140912@2910/16/2014
GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE)20140722@510/20/2014
 20140723@4510/21/2014
GLUTATHIONE (PRES) 100MG/ML INJECTABLE20140721@25/0011/18/2014
 20140902@4712/31/2014
GLUTATHIONE 100 MG/ML INJECTABLE20140718@410/16/2014
HYALURONIDASE 240U/ML INJECTABLE20140818@272/21/2015
HYDROXOCOBALAMIN-PF (B12) 1MG/ML INJ20140717@610/15/2014
HYDROXOCOBALAMIN-PRES (B12) 1MG/ML INJ20140729@1810/27/2014
HYDROXYPROGESTERONE CAPROATE (SESAME OIL) 250MG/ML INJ20140718@1/51/14/2015
 20140813@252/9/2015
 20140903@323/2/2015
LIDOCAINE HCL (REPKG-STERILE) 4% SOLUTION20140815@122/16/2015
METHYCOBALAMIN (PF) 10MG/ML INJECTABLE20140729@16/111/26/2014
METHYCOBALAMIN (PF) 1MG/ML INJECTABLE20140722@2/21/18/2015
 20140910@40/23/9/2015
METHYCOBALAMIN (PF) 20MG/ML INJECTABLE20140718@2/0.31/14/2015
 20140808@4/0.32/4/2015
 20140902@36/13/1/2015
 20140902@37/0.33/1/2015
 20140912@223/11/2015
METHYCOBALAMIN (PRES) 1MG/ML INJECTABLE20140715@210/13/2014
 20140724@1010/22/2014
 20140812@1411/1/2014
 20140826@511/1/2014
MITOMYCIN 0.2MG/ML INJECTABLE20140913@110/28/2014
MITOMYCIN 0.3MG/ML INJECTABLE20140913@410/28/2014
OMNIPAQUE (REPKG) 300MGI/ML INJECTABLE20140711@11/7/2015
 20140814@222/10/2015
 20140815@132/11/2015
PAPAV HCL/PHENTOL/PROSTAGL 12/1/10 INJECTABLE20140827@3010/11/2014
 20140910@2810/25/2014
 20140917@2/1.2511/1/2014
PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL 21.82/0.91/45 INJ20140722@16/1.712/3/2014
 20140728@43/212/3/2014
PAPAVERINE HCL (PRES) 30 MG/ML INJECTABLE20140903@14/1.2510/18/2014
PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL 22MG/0.8MG/8MCG INJ20140901@310/19/2014
PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN 23/0.96/19.23 ML INJ20140708@3012/2/2014
PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN 27.70/0.45/45.45 INJ20140912@2510/27/2014
PAPAVERINE/PHENTOLAMINE/ALPROSTADIL 26.5/0.98/58.9 INJ20140910@48/1.2510/25/2014
 20140911@11/1.2510/26/2014
 20140916@17/1.2510/31/2014
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN 17.16/0.57/19.45 INJ20140728@3912/3/2014
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN 17.44/0.64/5.8 INJ20140910@421/25/2015
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN 17.64/0.58/5.88 INJ20140828@4/1.710/15/2014
PREDNISOLONE SOD PHOS 1% OPTHAMALIC20140902@2210/17/2014
PROCAINE HCL (BUFF) 1% INJECTABLE20140905@1112/4/2014
PYRIDOXINE HCL (PRES)100 MG/ML INJECTABLE20140715@1810/13/2014
 20140917@1812/16/2014
SODIUM CHLORIDE INHALATION 7% SOLUTION20140916@2310/31/2014
TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED) 200MG/ML INJ20140812@72/8/2015
 20140910@413/9/2015
TESTOSTERONE CYPIONATE (SESAME OIL/CMPD)20140714@511/10/2015
TOBRAMYCIN 480MG/1000 ML IRRIG20140912@1610/17/2014
TRIESENCE (SYRINGE-REPKG) 8MG/2.0ML INJ20140909@610/24/2014
VANCOMYCIN (SYRINGE) 1MG/0.1ML INJ20140905@3210/20/2014
VITAMIN B COMPLEX(PRES) 100 INJ20140811@510/16/2014
 20140827@1211/25/2014
Veterinary Products
MedicationLot NumberDiscard Date
APOMORPHINE HCL 3MG/ML INJECTABLE20140818@3711/16/2014
CYCLOSPORINE-E PLUS 2% OPHTHALMIC20140702@1212/29/2014
POLYSULF GLUCOSAMIN GLYCAN 10% INJECTABLE20140820@7/3011/18/2014

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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 
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