FDA Finds Impurity In Suspect Heparin Batches

Law360, New York (March 19, 2008, 12:00 AM EDT) -- Federal regulators have identified a contaminant in batches of heparin linked to 19 deaths and hundreds of allergic reactions in the U.S. and are working to figure out how the blood thinner got contaminated.

In a press conference Wednesday, the U.S. Food and Drug Administration identified the contaminant as oversulfated chondroitin sulfate, a chemically altered form of chondroitin sulfate.

Tests on heparin batches originating from China have shown that the contaminant accounts for as much as 50% of the active ingredient.

While chondroitin sulfate is naturally...
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