The FDA has seized 11 lots of heparin from Celsus Laboratories in Cincinnati.
The five lots of Heparin sodium active pharmaceutical ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. The 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, acting associate commissioner for regulatory affairs at the FDA.
OSCS has been linked to multiple adverse events and deaths initially reported to the FDA in January. Since then, the FDA has established an inspection and import controls program, and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin—which had entered the U.S. before the establishment of import controls for the drug—was tested for the presence of OSCS as part of the FDA effort.
To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.
The FDA said it informed Celsus Laboratories during an April inspection, and again in a May 8 letter, that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advised manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.