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.

Tainted Heparin Recalls Spurs FDA in China

Earlier this year, the FDA discovered that contaminated heparin, a blood thinner manufactured in China, had been linked to dozens of deaths. The heparin was laced with a contaminant that mimics real heparin. Several Toledo residents filed wrongful death lawsuits.

Other problems with food and drugs imported from China included pet food, milk products, candy, pet food, and toys with lead. Is China trying to poison us?

What is way overdue but finally happened is that the FDA opened its first office in Beijing after all this contamination. Much more stringent oversight is needed.

More FDA offices will open in Guangzhou and Shanghai plus subsequent locations will include India, the Middle East, Latin America and Europe. FDA employees would inspect products and develop liaisons with Chinese officials and groups.