Baxter’s heparin product, lately in the news because of recent side-effect problems, sourced its active pharmaceutical ingredient from a US supplier who, in turn, manufactured the drug in a China subsidiary. Even worse, the FDA was supposed to inspect the subsidiary, but some snafu prevented the inspection from ever taking place. So far in 2008, the FDA has received 350 reports of problems that may have been caused by Baxter’s heparin. Of the 350 incidents, 40% were termed serious, such as septic shock, and there are four deaths associated with the drug, though the causal link has not been definitively established. More details...

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