Genzyme Recalls Leukemia Meds Over Factory Concerns

Law360, New York (February 16, 2012, 2:55 PM EST) -- A U.S. subsidiary of French drug giant Sanofi has voluntarily recalled more than 9,000 vials of the intravenous leukemia drug Fludara because of sterility concerns stemming from a U.S. Food and Drug Administration inspection of the Ohio manufacturing facility, the FDA said Wednesday.

In an enforcement report issued Wednesday, the FDA said Massachusetts-based Genzyme Corp. issued nationwide recall letters on Jan. 31 and Feb. 1 for 9,380 50-mg, single-dose vials of Fludara, the company’s brand of fludarabine phosphate.

The recall came after the FDA and the...
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