November 1, 2010 (Irvine, California) — Medical product and services provider B Braun Medical [1], based here, and the FDA [2] have announced a recall of seven lots of heparin the company manufactured in 2008. Five of the lots have expiration dates of 10/31/2010 and two expire on 11/30/2010, according to a company announcement that also lists the affected lot numbers. There have been no reports of adverse reactions involving the recalled lots.

B Braun Medical issued the recall, it said, because of a recall by its supplier, Scientific Protein Laboratories (SPL), of the crude heparin (heparin sodium active pharmaceutical ingredient) it uses to manufacture the final product. SPL recalled one lot of the crude heparin in which it had found a "trace amount" of oversulfated chondroitin sulfate.

It comes two weeks after reports that the FDA has reprimanded SPL for failing to investigate complaints in October 2008 that some of its product had been contaminated, even after the heparin recalls earlier that year--in which SPL had been involved--which had caused shortages of the drug in the US.

Those recalls in early 2008 had been issued after reports of adverse events and some deaths in >800 patients who received certain lots that, it was ultimately found, and as covered extensively by heartwire , had probably been contaminated by oversulfated chondroitin sulfate at factories in China.


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