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U.S. Department of Health and Human Services


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B. Braun Heparin Sodium in 5 Percent Dextrose and 0.9 Percent Sodium Chloride Injection Solution

Audience: Surgeons, dialysis center staff, hospital risk managers, other healthcare professionals

[Posted 03/21/2008] B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.

[March 21, 2008 - Press Release - B. Braun Medical]