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U.S. FDA Probes Devices For Possible Contaminated Heparin

This article was originally published in PharmAsia News

Executive Summary

U.S. FDA says it has received 97 reports, 11 of them of deaths, so far this year of adverse events that may have involved devices such as oxygenators and flush solutions containing heparin. The agency said it has not been able to determine the cause of the events and or whether contaminated heparin, such as the Chinese batch linked to 81 other deaths, were contained in the devices. The only two cases traced by the FDA so far showed the heparin was not contaminated, an agency spokeswoman said. (Click here for more - a subscription may be required

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