The FDA Calls on Health Professionals to Ensure the Proper Recall of Heparin Products
May 9, 2008 – The Food and Drug Administration (FDA) is asking health professionals and facilities to examine all drug/device storage areas, including emergency kits, dialysis units, and automated drug storage cabinets, to ensure that all recalled injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate have been removed and are no longer available for patient use.
Although the recall instructions were widely distributed, affected heparin products have been found in medical facilities in one state since the February 2008 recall announcement. There have also been reports of deaths associated with allergic or hypotensive symptoms after administration of heparin, and officials believe the recall may not have been fully acted upon at all locations where heparin is used.
Additionally, the FDA would like to make health professionals aware of other medical devices that contain, or are coated with, heparin.
|