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.
Genzyme is conducting the recall as a precautionary measure after Ben Venue was cited last year by the FDA and the European Medicines Agency for “serious deficiencies,” Genzyme said today in an e-mail sent by Carrie Brown, a company spokeswoman.
“No issue has been identified with Fludara,” the company said. “However, defects potentially associated” with deficiencies at Ben Venue “raise the possibility for hypersensitivity reactions.”
The recalled vials comprised one batch. Fludara hasn’t been manufactured at the Ohio plant since June 2010, Genzyme said.
Genzyme bought Fludara from German drugmaker Bayer AG in 2009. The medicine is available in generic form.
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