Saturday, March 15, 2008

influx of reports describing allergic reactions, including four fatalities, which may be linked to contaminated product.

Heparin Stopped at the Border | By MedHeadlines • Mar 15th, 2008 • Category: Drugs, FDA, Poisoning, Prevention, Recalls

On Friday, the US Food and Drug Administration (FDA) announced that it is taking action against shipments of heparin coming into the country from China after an influx of reports describing allergic reactions, including four fatalities, which may be linked to contaminated product. All shipments reaching the US border will now be tested for contamination before further distribution.
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FDA officials announced last week that they discovered a significant amount of a suspicious substance, thought to be a contaminant, in samples of some recalled heparin and in the active ingredient used to manufacture it. The substance is said to be “heparin-like” but it has yet to be identified exactly. Baxter issued a recall of most of its heparin products last month after receiving reports of adverse allergic reactions.

A heparin manufacturer in Germany issued reports of contaminated heparin last week and ordered a recall of all its products. Rotexmedica GmbH also purchases heparin ingredients from China ...

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