Pharmacy Recalls Compounded Drugs Due to Sterility Concerns

JULY 27, 2015
Krystle Vermes
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
 


SHARE THIS SHARE THIS
0
Pharmacy Times Strategic Alliance
 

Pharmacist Education
Clinical features with downloadable PDFs


Next-Generation Pharmacist® Awards


SIGN UP FOR THE PHARMACY TIMES NEWSLETTER
Personalize the information you receive by selecting targeted content and special offers.