Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which were distributed to physicians and patients across multiple states. The drugs, which are unexpired, are being recalled at 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 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 |
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 events involving animals can be reported to the FDA on Form FDA 1932a. FORM FDA 1932a can be found at:
https://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.