China Investigates Heparin Recall Case

Armen Hareyan's picture
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China State Food and Drug Administration is investigating the case of recalled Baxter's heparin and checking pharmaceutical ingredients used in the drug.

Heparin is number one blood thinner drug used worldwide for kidney dialysis and surgeries. It was recalled in early February because of four deaths and numerous serious allergic reaction. The recall posed panic among health officials, because they have no alternative they can use instead of heparin.

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China SFDA and US FDA are now cooperating to check the factory producing heparin and to find out the cause of recall. An agreement in late 2007 between Washington and Beijing put high responsibilities on food and drug safety to calm the scandals down around tainted or substandard products. FDA announced significant improvement after the agreement signed. However, this heparin case posed even more scandals, and the administration is doing the best to find out the reason of why the product lacks safety.

According to FDA announcement, they "are conducting inspections at a Baxter facility in New Jersey, at company supplier Scientific Protein Laboratories of Wisconsin and at Changzhou SPL, a factory in the eastern Chinese city of Changzhou that is 55 percent owned by Scientific Protein Laboratories." China SFDA is also checking the factory, but they don't give any details about the investigation.

Changzhou SPL appears never been checked by FDA, because as Chinese officials say, it is registered as a chemicals manufacturer instead of being registered as a pharmaceutical company. The major part of the recall seems to be caused by China. However, SFDA clearly mentions that drug importing country is mainly responsible for safety and quality of imported pharmacy.

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