As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.
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. 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, acting associate commissioner for regulatory affairs, FDA.
Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. 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. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.