A large number of hospitals, medical societies and pharmaceutical organizations were warned despite a recall by the California Department of Health and the FDA's own recall monitoring. Baxter International Inc., the largest supplier of heparin, also showed gaps in the recall response.
"Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement," the FDA notice read.
"Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used," it said.
According to Karen Riley of the FDA, many medical facilities were found not to have removed the contaminated heparin. California authorities sent a letter on May 2 about gaps in the recall response.
Heparin, a highly-sulfated glycosaminoglycan, is widely used as an injectable anticoagulant and has the highest negative charge density of any known biological molecule.
In March 2008, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. The FDA admitted that it had violated its own policies by failing to inspect the American pharmaceutical firm Scientific Protein's plant in China before approving the drug for sale.
At least 19 deaths were believed linked to a raw heparin ingredient imported from the People's Republic of China, and that the agency said it also had received 785 reports of serious injuries associated with the drug's use.
The contaminant has been identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish-derived supplement often used for arthritis. Since this "over-sulphated" variant is not naturally occurring and mimics the properties of heparin, the contamination could be an intentional counterfeit as opposed to an accidental lapse in manufacturing.
