Heparin Sodium - Voluntary Recall of 7 lots of B. Braun Heparin Products
November 2, 2010
B. Braun Medical Inc. (B.Braun) is voluntarily recalling 7 lots of heparin injection products manufactured in 2008 due to possible contamination of the active component.
Scientific Protein Laboratories LLC recently recalled one lot of Heparin Sodium USP Active Pharmaceutical Ingredient which had been sold to B. Braun. Testing of samples of crude heparin used in the manufacture of the Heparin Sodium USP Active Pharmaceutical Ingredient showed a trace amount of oversulfated chondroitin sulfate contamination.
B. Braun has not received any reports of adverse events associated with use of the specific finished lots involved in the B. Braun recall. The recalled lots expire on either October 31, 2010 or November 30, 2010. The affected lot numbers are listed in the Firm Press Release which may be accessed via the link below.
Discontinue use of product from the recalled lots immediately. Patients experiencing adverse events possibly related to the use of these products should consult a physician. Customers may contact B. Braun for drug handling instructions and product replacement information at 1-800-227-2862.
Additional information is available at the following links:
- MedWatch Alert:
- Firm Press Release (with list of recalled lots):
November 2, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.