March 3, 2008
Baxter International, the manufacturer of heparin, issued an urgent nationwide voluntary recall of its blood-thinner, Heparin. According to the New York Times, there were problems with a Chinese plant that supplied an active ingredient. Here’s a link to the FDA’s recall and an excerpt from the New York Times article:
The Food and Drug Administration said the number of deaths possibly associated with the drug, made from pig intestines, had risen to 21 from 4. But it cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths.
The F.D.A. emphasized that it had yet to identify the root cause of the problem, and that it had not concluded that the Chinese plant was responsible. The agency also said it was investigating two Chinese wholesalers — also called consolidators — that supplied crude heparin to the Chinese plant, Changzhou SPL, as well as those that sold raw ingredients to the consolidators.
The New York Times reported Thursday that at least one of the consolidators received supplies from small, unregulated family workshops that scraped mucous membrane from pig intestines and cooked it, eventually producing a dry substance known as crude heparin.
The F.D.A. admitted this month that it had violated its own policy by failing to inspect SPL, located west of Shanghai, before the factory began shipping the heparin ingredient to Baxter in 2004. China’s drug agency also did not inspect the plant.
The FDA’s failure is troubling, particularly in light of the Supreme Court’s recent preemption leanings.
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