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April 01, 2008

Heparin Contaminant Identified

Late February certain lots of Heparin were recalled and have been associated with 19 deaths. The lots have also been linked to hundreds of allergic reactions and were marketed by Baxter International and produced in China. The Food and Drug Administration’s have identified the contaminant found as oversulfated condroitin sulfate. Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said “We cannot rule in or out whether this was accidentally or deliberately introduced into the product,” Woodcock said, “We are investigating how it got in.” Condroitin sulfate is a compound in the same family as heparin, so preliminary testing did not identify it, Woodcock said. A different brand of heparin has also been recalled in Germany after 80 patients there became sick, and the German manufacturer said preliminary research has linked the source of contamination to another Chinese supplier. Heparin is made from pig intestines and tiny Chinese family-run workshops near slaughterhouses send the raw ingredients for the manufacturer of Heparin to middlemen before they reach factories.

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