Seven lots of heparin injection products have been recalled by B. Braun Medical Inc. because of concerns the <"http://www.yourlawyer.com/topics/overview/heparin">heparin products could be contaminated with a counterfeit ingredient. According to the recall notice, the recalled heparin products lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.
B. Braun initiated the recall after being notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API). Additional testing of retained crude heparin samples used by SPL to manufacture that single API lot indicated a trace amount of oversulfated chondroitin sulfate contaminant.
B. Braun has not received any reports of adverse events related to finished heparin products manufactured using this API. The company also maintains that, based on current information, the recalled lots do not pose a significant health risk. B. Braun has characterized this voluntary recall as a precautionary measure, and is undertaking it with the support of the U.S. Food and Drug Administration (FDA).
A complete listing of the lots included in this recall can be found here.
This is not the fist time heparin products have been recalled because of issues involving contamination by oversulfated chondroitin sulfate. In January 2008, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme â€“ and in some cases fatal â€“ allergic reactions, after being administered the products. The FDA ultimately initiated 13 recalls of multiple contaminated medical products containing heparin from several companies. Eighty-one US deaths were ultimately tied to the contaminated heparin.
In March 2008, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparinâ€™s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based SPL. The FDA investigation has never identified the culprits in the contamination, with the agency maintaining that there were too many sources to trace.
Two weeks ago, the FDA reprimanded SPL for failing to investigate complaints in October 2008 that some of its product had been contaminated, even after the heparin recalls earlier that year.