Quality & Patient Safety

FDA finds contamination in heparin samples

Patient Safety Monitor Alert, March 12, 2008

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The Food and Drug Administration (FDA) found 5% to 20% of heparin samples distributed by Baxter International to be contaminated, reports The Boston Globe. The number of deaths associated with this contaminant rose from four to 19, though it's not certain that the causes of death are specifically related to the contaminated heparin. Much of the heparin used in the U.S. is manufactured in China, says the FDA, and an investigation is being launched into whether the contaminated heparin was created by faulty manufacturing, or purposely to reduce costs.

Heparin, used to treat blood clots, is produced from pig intestines and creates $30 million in profit for Baxter.

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