The Heparin scare continues. US Marshals grabbed 11 lots of Heparin from Celsus Laboratories in Cincinnati, Ohio - five lots of Heparin Sodium active pharmaceutical ingredient and six lots of Heparin Lithium. The products were made from material imported from China and were OSCS, a substance that mimics heparin’s anticoagulant activity, according to the FDA.

The FDA informed Celsus Labs during an April 2008 inspection and again in a May 8, 2008, letter that its actions to notify customers about a contaminant in its Heparin were insufficient to assure an effective recall, according to an agency statement. So far, the FDA has initiated 13 recalls of multiple contaminated medical products containing Heparin from several companies (background here and here).

Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the US and abroad. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes.

OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. The seized Celsus Heparin – which had entered the US before the establishment of import controls for the drug – was tested for the presence of OSCS as part of the agency’s recent efforts to inspect and monitor Heparin products.