Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington

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

Medication

Lot Number

Discard Date

ALPROSTADIL 10 MCG/ML INJECTABLE

20140913@10

10/28/2014

ALPROSTADIL/LIDOCAINE HCL
20MCG/5MG/ML

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
INJECTABLE

20140827@34

10/26/2014

 

20140909@22

11/8/2014

 

20140912@2

11/11/2014

AVASTIN (SYRINGE-REPKG) 1.25MG/0.5ML
INJECTABLE

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

 

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

BEVACIZUMAB/DEXAMETHASONE (SYRINGE)
1.25/0.5 ML INJECTABLE

20140916@3

12/15/2014

CALCIUM CHLORIDE (COMPOUND) 100 MG/ML
INJECTABLE

20140815@47

1/28/2015

CEFTAZIDIME (SYRINGE) 2.25/0.1ML
INJECTABLE

20140905@33

10/20/2014

CHORIONIC GONADTROPIN (STERILE) 4000
UNITS POWDER

20140728@55

1/14/2015

 

20140915@14

3/8/2015

CHORIONIC GONADOTROPIN (STERILE) 5000
UNITS POWDER

20140909@5

3/8/2015

 

20140728@57

1/14/2015

CITRIC ACID/GLUCONOLACTONE MAGNES
CARB (RENACIDIN) 66/1.98/31.77 MG/ML

20140908@2

10/23/2014

COPPER (SULF) 0.4 MG/ML INJECTABLE

20140919@21

11/3/2014

DEXAMETHASONE (AS SOD PHOS) 24 MG/ML
INJECTABLE

20140903@10

10/18/2014

DEXPANTHENOL – (PRES) 250 MG/ML
INJECTABLE

20140828@14

11/26/2014

DMPS-PRES FREE 50 MG/ML INJECTABLE

20140724@24/5

10/22/2014

 

20140724@25

10/22/2014

 

20140826@12

11/24/2014

EPINEPHRINE/WATER (PF) 1:1000 INJECTABLE

20140913@2

10/18/2014

ESTRADIOL CYPIONATE
(COMPOUNDED/GRAPESEED OIL) 5 MG/ML
INJECTABLE

20140828@15

10/12/2014

GANCICLOVIR (PF) 2MG/0.1ML INJECTABLE

20140916@16

10/31/2014

GANCICLOVIR (PF) 0.2MG/0.1ML INJECTABLE

20140911@9

10/26/2014

GENTAMICIN SULFATE 100MG/1000ML
IRRIGATION

20140917@27

10/22/2014

GENTAMICIN SULFATE 480MG/1000ML IRRIG

20140912@29

10/16/2014

GLUTARALDEHYDE BUFFERED (POTASSIUM
PHOSPHATE)

20140722@5

10/20/2014

 

20140723@45

10/21/2014

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

HYDROXOCOBALAMIN-PRES (B12) 1MG/ML INJ

20140729@18

10/27/2014

HYDROXYPROGESTERONE CAPROATE
(SESAME OIL) 250MG/ML INJ

20140718@1/5

1/14/2015

 

20140813@25

2/9/2015

 

20140903@32

3/2/2015

LIDOCAINE HCL (REPKG-STERILE) 4%
SOLUTION

20140815@12

2/16/2015

METHYCOBALAMIN (PF) 10MG/ML
INJECTABLE

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
INJECTABLE

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
INJECTABLE

20140715@2

10/13/2014

 

20140724@10

10/22/2014

 

20140812@14

11/1/2014

 

20140826@5

11/1/2014

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
INJECTABLE

20140827@30

10/11/2014

 

20140910@28

10/25/2014

 

20140917@2/1.25

11/1/2014

PAPAVERINE
HCL/PHENTOLAMINE/ALPROSTADIL
21.82/0.91/45 INJ

20140722@16/1.7

12/3/2014

 

20140728@43/2

12/3/2014

PAPAVERINE HCL (PRES) 30 MG/ML
INJECTABLE

20140903@14/1.25

10/18/2014

PAPAVERINE HCL/PHENTOLAMINE
MES/ALPROSTADIL 22MG/0.8MG/8MCG INJ

20140901@3

10/19/2014

PAPAVERINE HCL/PHENTOLAMINE
MES/PROSTAGLANDIN 23/0.96/19.23 ML INJ

20140708@30

12/2/2014

PAPAVERINE
HCL/PHENTOLAMINE/PROSTAGLANDIN
27.70/0.45/45.45 INJ

20140912@25

10/27/2014

PAPAVERINE/PHENTOLAMINE/ALPROSTADIL
26.5/0.98/58.9 INJ

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
INJECTABLE

20140715@18

10/13/2014

 

20140917@18

12/16/2014

SODIUM CHLORIDE INHALATION 7%
SOLUTION

20140916@23

10/31/2014

TESTOSTERONE CYPIONATE (GRAPE SEED
OIL/COMPOUNDED) 200MG/ML INJ

20140812@7

2/8/2015

 

20140910@41

3/9/2015

TESTOSTERONE CYPIONATE (SESAME
OIL/CMPD)

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%
INJECTABLE

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

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