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news.B Braun Medical is initiating a voluntary recall of seven lots of heparin injection products due to supplier-initiated recall of heparin active pharmaceutical ingredient (API).
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B Braun was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), that an 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.
These lots were manufactured in 2008 and will be expiring on 31 October 2010 and 30 November 2010.
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 US Food and Drug Administration.