Med Prep Consulting Compounded Injectables
March 19, 2013
Med Prep Consulting, Inc. is voluntarily recalling all compounded products currently in circulation. A Connecticut hospital found visible particulate in magnesium sulfate 2 g/50 mL Dextrose 5% injection infusion bags compounded by Med Prep. These lots were isolated and contaminants were found in 5 bags, which were later confirmed to be mold. Serious infection could result from administering an IV product contaminated with mold. Med Prep had initially recalled their magnesium sulfate. However, as a precautionary measure, Med Prep is now recalling all compounded injectable products because sterility cannot be assured.
There have been no reports of patients harmed by Med Prep products. Currently, the FDA is not recommending health care professionals contact patients who received the affected products. Med Prep products were distributed to hospital pharmacies and clinics nationwide through March 13, 2013. The products are intended for administration in the healthcare setting and are not dispensed to patients. Facilities that received Med Prep products were individually notified of the recall. Health professionals currently stocking the products should stop using them and contact Med Prep at 732-493-3390 (weekdays, 10AM to 5PM Eastern Standard Time) to facilitate product return.
FDA encourages consumers and healthcare professionals to report adverse reactions to FDA’s MedWatch Program at www.fda.gov/medwatch.
- MedWatch Alert:
- Company Press Release & Product List, All Recalled Products, March 17, 2013:
- Company Press Release, Magnesium Sulfate Recall, March 16, 2013:
March 19, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.