Seven Lots of Heparin Recalled

Washington, DC: B. Braun Medical Inc. (B. Braun) was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because additional testing of retained crude heparin samples used by SPL to manufacture this single API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. As a result, B. Braun is initiating a voluntary recall of seven lots of heparin injection products to the healthcare provider level. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.

B. Braun has not received any reports of adverse events regarding the B. Braun finished products manufactured using this API.

Based on current information, the recalled lots do not pose a significant health risk; however, B. Braun is performing this voluntary recall as a precautionary measure with the support of the U.S. Food and Drug Administration (FDA).

Heparin is a blood thinner used to treat and prevent blood clots. The voluntary recall affects seven Finished Product (FP) lots manufactured in 2008 by B. Braun Medical Inc. and distributed nationwide to distributors and direct healthcare provider customers. For a complete list of affected product lots see the link below.

OCT-29-10: B. Braun Voluntarily Recalls Seven Lots of Heparin Manufactured in 2008 Due to Supplier-Initiated Recall of Heparin Active Pharmaceutical Ingredient (API) [FDA: RECALLS]

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Published on Oct-29-10