Contaminated Heparin Seized By FDA

Chrissie Cole

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The U.S. Food and Drug Administration (FDA) recently seized 11 lots of heparin from Celsus Laboratories Inc., in Cincinnati, Ohio.

U.S. Marshals seized five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium. The agency found the products, manufactured from material imported from China, to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that imitates heparin’s blood thinning activity.

Heparin sodium, is an injectable anticoagulant that is used to prevent blood from clotting in patients who undergo certain medical procedures. The drug was the center of a major recall initiated in January after crude material from China was found to be contaminated.

To date, the FDA has initiated 13 recalls of numerous contaminated products containing heparin from several companies. 250 deaths have been linked to the contaminated product and hundreds of patients have suffered serious adverse events.

The agency seized the contaminated heparin products after the company failed to adequately notify customers of the product contamination, stemming from an April investigation.