US FDA seizes contaminated heparin

The US Food and Drug Administration has seized 11 lots of heparin from Celsus Laboratories, in Cincinnati, Ohio. The five lots of heparin sodium active pharmaceutical ingredient and six lots of heparin lithium were seized by US Marshals at the federal agency's request. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

"This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, the FDA's Acting Associate Commissioner for Regulatory Affairs.

The contaminant is the same as in previous reports of contaminated heparin (Marketletters passim). The firm at the center the latest raid, Celsus, has distributed heparin sodium USP and heparin lithium to manufacturers in both the USA and other countries, the FDA said in a statement.