(Reuters) ? Sanofi said it has recalled some of its drug Fludara, a chemotherapy agent, due to quality control problems. The drug is used to treat adults with B-cell chronic lymphocytic leukemia who have failed to respond adequately to prior treatments.
On January 31, Sanofi's Genzyme unit informed the U.S. Food and Drug Administration that it was notifying customers of a limited recall of a specific lot of Fludara, also known as fludarabine phosphate.
Sanofi said in a statement the recall was being conducted as a precautionary measure after a third-party manufacturing facility, Ben Venue Laboratories, was cited by both European and U.S. regulators for serious manufacturing deficiencies that could produce "hypersensitivity reactions" in patients taking Fludara. Such allergic reactions can sometimes be severe.
No Fludara issues have been identified, the company said, although the defects raise the possibility of such reactions. Similar reactions have been associated with the active ingredient fludarabine but have not been clearly attributed to the Ben Venue Laboratories manufactured lot.
Since June 2010, Fludara has not been manufactured by Ben Venue Laboratories, so later batches are not part of this recall, the company said. Genzyme is not the sole manufacturer of fludarabine phosphate in the United States.
Genzyme, which makes drugs for rare diseases, had been battling quality control issues at its Boston area facility for several years before being acquired by Sanofi last year.
(Reporting By Toni Clarke in Boston; Editing by Maureen Bavdek)
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