FDA Seizes Tainted Heparin from Celsus

Rockville, MD (Nov. 6)-US marshals seized 11 lots of heparin from Celsus Laboratories (Cincinnati, OH) at the request of the US Food and Drug Administration. The seized products, five lots of heparin sodium active pharmaceutical ingredient (API) and six lots of heparin lithium, were manufactured from material imported from China. FDA had found the drugs to be contaminated with oversulfated 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 agency’s acting associate commissioner for regulatory affairs, in a press release.

In March 2008, Celsus adopted FDA’s recommended procedures for detecting contaminated heparin and began to investigate whether the integrity of its heparin had been affected, according to a company press release. Celsus identified and quarantined suspect heparin batches and informed customers in late March 2008 and early April 2008.

During FDA’s inspection of Celsus’s Cincinnati facility from April 15 through May 15, 2008, the company disclosed the suspect lot numbers, their quantities, and all of Celsus’s consignees to the agency. During the inspection and in a May 8, 2008 letter, the agency informed Celsus that the company had taken insufficient steps to alert customers about a contaminant in its heparin and to ensure an effective recall.

Celsus has distributed heparin sodium USP and heparin lithium to manufacturers in the US and around the world. FDA advises manufacturers that have purchased heparin from Celsus to contact the company and verify that they are not using heparin from the seized lots, which do not meet acceptable-quality standards.

According to a company press release, Celsus performs raw-material tests for OSCS and other impurities before it uses heparin in manufacturing. The company’s tests are consistent with the June 18, 2008 revision of the US Pharmacopeia monograph on heparin sodium.

Heparin is a blood-thinning drug. Heparin sodium USP is incorporated into finished drug products, and heparin lithium is used to coat capillary tubes and in medical devices such as vacutainer blood-collection tubes and in vitro diagnostic assays.

OSCS contamination in injectable drug products that contain heparin has been linked to adverse events and deaths that were first reported to FDA in January 2008. Since then, the agency has created an inspection and import-controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. FDA has initiated 13 recalls of contaminated medical products containing heparin from several companies.

For more about USP’s updated heparin monographs, see “USP Posts Revised Heparin Monographs.”