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FDA: Tainted Heparin Still Out There

FDA Now Warns of Heparin-Coated Devices Too

06/10/2008

Injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS) that have been recalled was found in medical care facilities in one state since the recall announcement.

“Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used,” a Food and Drug Administration (FDA) press release notes.
Many reports of deaths associated with allergic or hypotensive symptoms after heparin administration have been reported. For more information on the adverse events related to the heparin recall, click here.

FDA asks that health professionals and facilities please review and examine all drug/device storage areas — including emergency kits, dialysis units and automated drug storage cabinets — to ensure that all of the recalled heparin products have been removed and are no longer available for patient use.

In addition, FDA would like to inform health professionals about other types of medical devices that contain, or are coated with, heparin. To read this update, and to learn how to report these problems click here.

Please report to FDA adverse reactions associated with these devices, as well as any reactions associated with heparin or heparin flush solutions. If you have questions or would like more information about this request, call the Division of Drug Information at (301) 796-3400.

Source: FDA


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