FDA seizes tainted Celsus heparin

The heparin debacle that began in January is still haunting the drug industry. The FDA actually sent federal marshals to seize 11 lots of the blood thinner from Celsus Laboratories, a Cincinnati company that hadn't complied with the agency's repeated requests for a recall.

Celsus distributes heparin to drug and medical-device manufacturers in the U.S. and abroad. During an April inspection, the FDA found contaminated heparin in two kinds of products, some for use directly in patients and others intended for diagnostic kits and medical devices.

As you know, contaminated lots of the blood thinner--largely sold by Baxter--led to hundreds of allergic reactions and deaths earlier this year, triggering an international recall. The FDA eventually traced the contamination to facilities in China and identified the contaminant as over-sulfated chondroitin sulfate.

FDA found the same contaminant in Celsus' products. That company's heparin had entered the U.S. before the agency slapped import controls on the drug. Celsus notified customers that the contaminant had surfaced in its products, but FDA said that wasn't enough to ensure that the tainted heparin wouldn't be used. After the seizure, Mike Chappell, The FDA's acting associate commissioner for regulatory affairs, said, "This action will help prevent this contaminated heparin fro finding its way into the marketplace."

- read the USA Today story
- see the news from the Associated Press
- check out the article at PharmaTimes

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