"Contaminant" in Baxter's Recalled Heparin

At a teleconference this afternoon, CDER acting director Janet Woodcock indicated that a heparin-like contaminant has been found in some lots of Baxter's recalled heparin products, according to late-breaking news reports. The presence of a heparin-like substance, which has been found to make up as much as 25% of the (intended) active ingredient in the Baxter lots, raises the possibility of drug counterfeiting. However, it is presently unknown where the contaminent was introduced, whether its introduction was intentional, and whether it is related to the hundreds of adverse reactions and now-reported 19 deaths associated with the administration of Baxter's recalled drug.

In 1998, high endotoxin levels in counterfeit gentamicin from unvetted Chinese sources were linked to similar adverse reactions at a Los Angeles hospital.