Friday, October 29, 2010

FDA MedWatch - Heparin Sodium (B. Braun): Recall - Trace Contaminant

FdaImage via WikipediaFrom the FDA:

AUDIENCE: Pharmacy, Risk Managers
ISSUE: B. Braun Medical Inc. and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.

BACKGROUND: Heparin is a blood thinner used to treat and prevent blood clots.

RECOMMENDATION: Customers who have product from the recalled product lots in their possession should discontinue use immediately. Product lot numbers, expiration dates, and recall instructions are listed in the Press Release.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

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