FDA Seizes More Heparin

November 6, 2008—The FDA seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

Five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized by U.S. Marshals. The seized products were manufactured from material imported from China and were contaminated with over-sulfated chondroitin sulfate, a cheaper substance that mimics heparin's anticoagulant activity.

Heparin is a blood-thinning drug. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.

Over-sulfated chondroitin sulfate has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products with the cheap substitute.

The FDA has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories twice that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall.