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FDA seizes contaminated heparin lots in Cincinnati
The move is the latest in the FDA’s effort to remove contaminated heparin from the market.
At the request of the FDA, federal officials seized 11 lots of heparin from a facility in Cincinnati, according to a press release.
The seizure was part of an ongoing effort beginning in January 2008 to recall contaminated lots of heparin imported from manufacturers in China. Five lots of heparin sodium active pharmaceutical ingredient and six lots of heparin lithium were seized after the FDA found that they were contaminated with over sulfated chondroiton sulfate.
“This action will help prevent this contaminated heparin from finding its way into the marketplace,” Mike Chappell, acting associate commissioner for regulatory affairs at the FDA, said in a press release.
Celsus Laboratories Inc. in Cincinnati was the target of the seizure. The contaminated lots were imported into the United States prior to FDA imposition of import controls for the drug.
The FDA initiated a recall of the contaminated heparin lots after confirming reports of 131 deaths following heparin administration between 2007 and 2008 with 123 of the events being reported on or after Jan. 1, 2008. Baxter International Inc. had recalled nine lots of the contaminated heparin after receiving FDA warnings, expanding its recall to all heparin products and vial sizes in February.
The FDA investigated Baxter and Scientific Protein Laboratories in April and traced the contaminated lots to a manufacturing facility in Changzhou, China. After sending warning letters to the manufacturing facility in China, an FDA investigation found flaws in the processing steps used to screen out impurities and in the evaluation systems for heparin crude material suppliers as well as unsuitable manufacturing equipment.