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Sanofi (France) (SAN.PA)'s Genzyme Corporation (GENZ) Recalls 9,380 Vials of Fludara Leukemia Drug Made at Ben Venue Laboratories Plant


2/16/2012 7:22:44 AM

Sanofi, France’s biggest drugmaker, recalled 9,380 vials of the leukemia medicine Fludara because of a “lack of assurance of sterility,” U.S. regulators said. Genzyme, a unit of Paris-based Sanofi, notified customers of the recall of the intravenous drug on Jan. 31 and Feb. 1, the Food and Drug Administration said today in an enforcement report on its website. The nationwide recall was prompted by manufacturing deficiencies at Boehringer Ingelheim GmbH’s Ben Venue Laboratories that produced Fludara. Boehringer, the world’s largest family-owned drugmaker, closed the factory in Bedford, Ohio, last year after U.S. and European regulators discovered the violations.

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