Sanofi Recalls 9,380 Vials of Fludara

Sanofi, a unit of Genzyme, has issued a recall for 9,380 vials of Fludara because the leukemia drug may have a “lack of assurance of sterility”, according to U.S. regulators.

Bloomberg reports that the drug recall was prompted after U.S. and European regulators discovered violations at Boehringer Ingelheim GmbH’s Ben Venue Laboratories, the drug’s manufacturing plant.

While Genzyme stated that “no issue” had been specifically linked to Fludara, the company added that issues at Ben Venue could “raise the possibility for hypersensitivity reactions.”

Only one batch of Fludara vials were affected by the recall.

If you have been harmed by a dangerous drug such as Fludara, contact Sokolove Law for a free legal consultation and top find out if you have grounds to pursue legal action.