FDA Seizes Adulterated Heparin in Cincinnati
The U.S. Food and Drug Administration seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio earlier this week. Five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized by U.S. Marshals at the request of the FDA.
These products were found to be contaminated with over-sulfated chondroitin sulfate (OSCS) and were imported from China. OSCS mimics heparin’s anti-coagulant activity and it is suspected it was added for financial gain in China. Adulterated heparin led to adverse effects that sickened and killed dozens of Americans since the beginning of 2008.
The lots of heparin seized from Celsus Laboratories are thought to have entered the United States before the FDA began controlling the importation of the drug. The FDA states it notified Celsus Laboratories in April and May 2008 that “the company’s actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall.”
Manufacturers who purchased heparin from Celsus are asked to make sure they are not using any of the lots of heparin seized this week.