Recall issued due to presence of trace amounts of oversulfated chondroitin sulfate contaminant
MONDAY, Nov. 1 (HealthDay News) -- The U.S. Food and Drug Administration and B. Braun Medical Inc. have notified health care professionals of a nationwide, voluntary recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) due to the identification of trace amounts of oversulfated chondroitin sulfate (OSCS) contaminant.
B. Braun Medical issued the recall after being notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a recall of one lot of API sold to B. Braun Medical. Additional testing of retained crude heparin samples used by SPL to manufacture this lot indicated a trace amount of OSCS contaminant. The lots being recalled were manufactured in 2008 and expired Oct. 31 or will expire Nov. 30, 2010.
B. Braun Medical has not received any reports of adverse events associated with any products containing this API. The recall was issued as a precautionary measure, as the recalled lots do not pose any major health risk based on current information. The company is also notifying distributors and customers by certified mail and arranging for return of all recalled products.
According to an FDA safety alert, "customers who have product from the recalled product lots in their possession should discontinue use immediately."