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  Vol. 300 No. 22, December 10, 2008 TABLE OF CONTENTS
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Contaminated Heparin Seized by FDA

Mike Mitka

JAMA. 2008;300(22):2597.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The US Food and Drug Administration (FDA) sent federal marshals to Celsus Laboratories Inc in Cincinnati on November 6 to seize the remains of 11 lots of contaminated heparin after the agency felt the company failed to take sufficient action to recall the products (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01912.html).

Celsus said it had identified and quarantined suspect heparin batches following a March 6 disclosure from the FDA to the public of the potential presence of contaminated heparin imported from China containing oversulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. The company said customers who had received heparin from suspect batches were informed in late March and early April (http://www.celsuslaboratories.com/news.php).

The company went on to say the FDA, after receiving notice from Celsus customers, initiated a fact-finding inspection of its Cincinnati facility in April. That inspection resulted in the FDA informing Celsus that its actions to . . . [Full Text of this Article]



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