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Published on 7 November 2008

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Contaminated medicine seized in US

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Quantities of a blood-thinning drug have been seized from a manufacturer in the US after warnings that its ingredients were contaminated.

Heparin – given to patients undergoing heart surgery and kidney dialysis – was the focus of a major recall earlier this year after material from China used in the drug’s production was found to be contaminated.

The American government received reports of nearly 250 deaths after hundreds of frail patients suffered severe allergic reactions.

The US Food and Drug Administration (FDA) inspected Cincinnati company, Celsus Laboratories, in April and found contaminated heparin in two different kinds of products.

A little over 2lb (0.9kg) of the blood thinner was intended for use directly with patients, and another 31lb (14kg) was to be utilised in diagnostic test kits and medical devices.

The FDA said it seized the heparin after informing the company that its efforts to notify customers of the contamination problem were unsatisfactory.

Drug seizures are a rarely used penalty as FDA regulators prefer to negotiate with manufacturers to resolve disputes.

Copyright Press Association 2008

FDA



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