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Tainted Heparin Seized by FDA

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The Food & Drug Administration (FDA) has seized 11 lots of contaminated heparin from Celsus Laboratories in Cincinnati, OH. This included five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium.  According to the FDA, the heparin was tainted with over-sulfated chondroitin sulfate, a counterfeit ingredient that mimics heparin’s blood thinning properties.

According to the FDA, Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the U.S. and abroad. The agency is advising manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

According to an agency press release, the FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company’s actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall.

Heparin was the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China. In the first quarter of 2008, the FDA received 779 reports of serious injury in which heparin was the principal suspect drug, including 102 deaths.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in tainted heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

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