| ■ Contaminated Heparin Seized From Cincinnati Company | 2008.11.11 |
| Eleven contaminated lots of the blood-thinning drug heparin were seized from Celsus Laboratories Inc. in Cincinnati, the U.S. Food and Drug Administration said Thursday. The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium, which were manufactured from material imported from China, were contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. Heparin Sodium USP may be incorporated into finished drug products while 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 the United States and other countries, the FDA said. The agency has notified Australian, Canadian, European Union, Japanese and other international authorities about shipments of contaminated heparin from Celsus. |