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Screening Methods For Heparin Manufacturers

27. July 2008

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To ensure the safety of heparin products in the United States market, the FDA has asked companies that manufacture heparin-containing products to test the heparin active pharmaceutical ingredient (API) used in those products using capillary electrophoresis (CE) and the updated proton nuclear magnetic resonance (H-NMR) methods provided in the “Screening Methods” section of this website. […]

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Voluntary Heparin Recall by Medtronic

27. July 2008

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Medtronic, Inc. today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the U.S. […]

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Heparin Recall and Deaths

27. July 2008

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The FDA was in the hot seat on Capitol Hill after a tainted drug was implicated in multiple deaths. A recent study found that more than 80 percent of active ingredients in U.S. drugs come from abroad, but only 11 percent of foreign suppliers are investigated by the FDA.

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