Pharmacy Recalls Compounded Drugs Due to Sterility Concerns

A pharmacy in Washington is recalling unexpired human and veterinary compounded drugs due to concerns about their sterility.

Moses Lake Professional Pharmacy compounded these recalled products between July 21, 2014, and July 21, 2015. The drugs were then dispensed to patients or distributed to physicians to administer to patients in Arizona, Idaho, Florida, Oregon, Texas, and Washington.

The pharmacy issued the recall after a recent inspection identified an issue with sterility assurance. All recalled products have a label that includes the pharmacy name and the name of the compounded drug product. The recall does not affect any non-sterile compounded medications it prepared, or any sterile products it compounded after July 21, 2015.

Although the compounding pharmacy has not received any reports of adverse events or product contamination to date, patients who use tainted products intended to be sterile could face risk for serious infections that may be life threatening.

“We are fully cooperating with the FDA and we regret any impact this voluntary recall may have on our patients,” stated Moses Lake Professional Pharmacy owner and pharmacist Shawn Needham, RPh. “Patient safety is our highest priority.”

The company has already begun notifying patients of the recall via telephone, fax, regular mail, and e-mail. The FDA advised recipients of recalled unexpired products to immediately discontinue use and return them to the pharmacy.

Unexpired lots of the following sterile compounded products have been recalled:

ALPROSTADIL 20 MCG/ML INJ SOLN

ALPROSTADIL 5 MCG/ML INJ SOLN

ALPROSTADIL 40 MCG/ML INJECTABLE

ALPROSTADIL/PROCAINE 20 MCG/0.1%/ML INJECTABLE

ALPROSTADIL/PROCAINE 40 MCG/0.1%/ML INJECTABLE

B1/B2/B3/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL 50/5/50/5/1/10/25/8/17/17MG/ML INJECTABLE

BUPRENORPHINE MULTIDOSE VIAL 0.3MG/ML INJ SOLN

CALM ME VITAMIN COCKTAIL, MAGNESIUM, COMPOUNDED B COMPLEX INJECTABLE

CHORIONIC GONADOTROPIN INJECTION 4000 UNITS/ML INJECTABLE

CHORIONIC GONADOTROPIN 1000UNITS/0.1ML INJECTION 10,000 UNITS/ML INJECTABLE

CHORIONIC GONADOTROPIN 175 UNITS/SYRINGE W METHYLCOBALAMIN 175 UNITS/1.5MG INJECTABLE

CHORIONIC GONADOTROPIN 200UNITS/0.1ML INJECTION 2000 UNITS/ML INJECTABLE

CHORIONIC GONADOTROPIN 500UNITS/0.1ML INJECTION 5000 UNITS/ML INJECTABLE

CHORIONIC GONADOTROPIN COMPOUNDED 150 UNITS/SYRINGE 150 UNITS/0.150ML INJECTABLE

CHORIONIC GONADOTROPIN COMPOUNDED 175 UNITS/SYRINGE 175 UNITS/0.175ML INJECTABLE

CHORIONIC GONADOTROPIN COMPOUNDED 200 UNITS/SYRINGE 200 UNITS/0.2ML INJECTABLE

CHORIONIC GONADOTROPIN COMPOUNDED 250 UNITS/SYRINGE 250 UNITS/0.25ML INJECTABLE

CYANOCOBALAMIN MDV (COMPOUNDED) 1MG/ML INJECTABLE

CYCLOSPORIN DROPS 1% OPHTHAMLIC

DEXPANTHENOL 250MG/ML INJECTABLE

DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE>

DMPS (DIMERCAPTO-PROPANESULFONIC NA (SINGLE USE ONLY) 50MG/ML INJECTABLE

EDETATE CALCIUM DISODIUM (SINGLE USE ONLY) 300MG/ML INJECTABLE

ESTRADIOL 20MG/ML INJECTABLE

ESTRADIOL 3MG PELLET

ESTRADIOL 6MG PELLET

ESTRADIOL 9MG PELLET

ESTRADIOL 12MG PELLET

ESTRADIOL 12.5MG PELLET

ESTRADIOL 15MG PELLET

ESTRADIOL 18MG PELLET

ESTRADIOL 20MG PELLET

ESTRADIOL 25MG PELLET

ESTRADIOL 30MG PELLET

ESTRADIOL 75MG PELLET

ETHYL ALCOHOL 200 PROOF (STERILE FOR INJECTION) 100% INJECTABLE

FOLIC ACID 10MG/ML INJECTABLE

GLUTATHIONE MDV 200MG/ML INJECTABLE

GLUTATHIONE (L) 75/ML INJECTABLE

GLYCOPYRROLATE 0.2 MG/ML INJ SOLN

HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES 1.5MG/0.25ML INJECTABLE

HYDROXOCOBALAMIN (COMPOUNDED) 1MG/ML INJECTABLE

HYDROXOCOBALAMIN MULTIDOSE VIAL 5MG/ML INJECTABLE

HYDROXYCOBALAMINE/METHYLCOBALAMINE PF UNIT DOSE 1.5/1.5MG/.25ML INJECTABLE

HYDROXYPROGESTERONE CAPROATE OIL 250MG/ML INJECTABLE

MEDROXYPROGESTERONE ACETATE INJECTION VEHICLE 200MG/ML

METHIONINE/CHOLINE/INOSITOL 25/50/50MG/ML INJECTABLE

METHYLCOBALAMIN 10MG/ML INJECTABLE

METHYLCOBALAMIN 15MG/ML INJECTABLE

METHYLCOBALAMIN MDV 1MG/ML INJECTABLE

METHYLCOBALAMIN MDV 2MG/ML INJECTABLE

METHYLCOBALAMIN MDV 5MG/ML INJECTABLE

METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED 1MG/ML INJECTABLE

METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED 15MG/ML INJECTABL

METHYLCOBALAMIN/HYDROXOCOBALAMIN PRESERVATIVE FREE UNIT DOSE SYRINGES 2.5/0.5MG/ML INJECTABLE

PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML INJECTABLE

PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLADIN PER ML 30MG/2MG/0.1MG/20MCG INJECTABLE

PROCAINE MDV 1% INJECTABLE

PROGESTERONE 50MG PELLET

PROGESTERONE 100MG PELLET

PROGESTERONE 200MG PELLET

PYRIDOXINE HCL 100MG/ML INJECTABLE

SERMORELIN/GHRP-6/GHRP-2 9/5.4/5.4MG/9ML INJECTABLE

SERMORELIN/GHRP-6/GHRP-2 9/9/9MG/9ML INJECTABLE

SODIUM TETRADECYL SULFATE 3% INJECTABLE

TESTOSTERONE CYPIONATE (COMPOUNDED) 200MG/ML INJECTABLE

TESTOSTERONE 25MG PELLET

TESTOSTERONE 50MG PELLET

TESTOSTERONE 60MG PELLET

TESTOSTERONE 70MG PELLET

TESTOSTERONE 76MG PELLET

TESTOSTERONE 80MG PELLET

TESTOSTERONE 90MG PELLET

TESTOSTERONE 100MG PELLET

TESTOSTERONE 106MG PELLET

TESTOSTERONE 110MG PELLET

TESTOSTERONE 112MG PELLET

TESTOSTERONE 115MG PELLET

TESTOSTERONE 116MG PELLET

TESTOSTERONE 120MG PELLET

TESTOSTERONE 125MG PELLET

TESTOSTERONE 130MG PELLET

TESTOSTERONE 150MG PELLET

TESTOSTERONE 200MG PELLET

TESTOSTERONE/ANASTROZOLE 200/13MG PELLET

TESTOSTERONE/ANASTROZOLE 120/8MG PELLET

THIAMIN/RIBOFLAVIN/NIACIN/PYRIDOXINE/BIOTIN/FOLIC ACID/ METHYLCOBALAMIN 50MG/50MG/50MG/50MG/400MCG/800MCG/500MCG/5ML SOLUTION

TRIMIX 30MG/2MG/20MCG INJECTABLE

TRIMIX 40MG/2MG/40MCG/ML INJECTABLE

TRIMIX 15MG/.5MG/5MCG/ML INJECTABLE

TRIMIX 20MG/1MG/20MCG/ML INJECTABLE

VITAMIN A/VITAMIN C/VITAMIN E/LIPOIC ACID/COQ10 5000U/500MG/200U/200MG/30MG/5ML SUSPENSION

VITAMIN B-COMPLEX B1/B3/B2/B5/B6/B12 100/100/2/2/2/3MG/ML INJECTABLE

VITAMIN D3 OIL 400,000 UNITS/ML INJECTABLE

VITAMIN D3 OIL 50,000 UNITS/ML INJECTABLE