After asking a Cincinnati based manufacturer of medical products to recall contaminated heparin and the manufacturer not answering, FDA seized the contaminated heparin. This past Thursday, FDA sent US marshals to seize 11 lots of the heparin drug. Heparin is a blood-thinning drug. Celsus Laboratories is the company who distributes heparin to medical devise and drug manufacturers nationwide and internationally.
It was in January when FDA testing discovered large amounts of Chinese raw heparin that were imported the United States. They were contaminated with oversulfated chondroitin sulfate. Close to 250 deaths and hundreds of severe allergic reactions that Elizabeth Weise wrote in the USA Today said “were blamed on tainted batches of the blood thinner, which is frequently given to patients having heart surgery and kidney dialysis.”
FDA says that companies who may have purchased heparin from Celsus should contact the company as soon as possible to determine if the heparin they purchased was included in the seized lots.
This was a good move by the FDA because Mike Chappell (an acting associate commissioner for regulatory affairs in a statement) said, “This action will help prevent this contaminated heparin from finding its way into the marketplace.”
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