Moses Lake Professional Pharmacy Issues Voluntary Recall of Unexpired Sterile Human and Veterinary Compounded Drugs Due to Lack of Sterility Assurance

Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which are unexpired 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, and 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 contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

The recalled products were made from 7/21/2014 through 7/21/2015, and dispensed to patients or distributed to physicians for further administering to patients in the states of Arizona, Idaho, Florida, Oregon, Texas, and Washington. All recalled products have a label that includes the pharmacy name and the name of the compounded drug product.

The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy or to products compounded after July 21, 2015.

All unexpired lots of the following sterile compounded products are subject to the recall:

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 INJECTABLE
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

The pharmacy has begun notifying its patients 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 509-764-2314, Monday through Friday, from 8:30 a.m. to 12:30 p.m. and 1 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 human drugs may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit a report Online 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.

Adverse events involving animals can be reported to the FDA on Form FDA 1932a. FORM FDA 1932a can be found at:

• http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/AnimalDrugForms/ucm048817.pdf
• It is preaddressed and pre-postage paid, and can be filled and submitted via US Mail.
• Call the Center for Veterinary Medicine: 1-888-FDA-VETS. Leave your name, address, phone number, and the brand name of the drug involved. Ask to have a Form FDA 1932a sent to you.

“We are fully cooperating with the FDA and we regret any impact this voluntary recall may have on our patients, and patient safety is our highest priority”, said Shawn Needham, R.Ph., owner and pharmacist.