Aug 28 (Reuters) - The U.S. health regulator said Sanofi’s rare disease division, Genzyme, voluntarily recalled nine lots of its drug Thymoglobulin, which treats transplant rejection in kidney transplant patients.
The recall was initiated on Aug. 2 when one lot of the drug failed a periodic stability test, a study to check the shelf life of a drug within specified conditions.
“Genzyme has not identified any new safety risk to patients who have received Thymoglobulin from the implicated lot numbers, and there are no confirmed safety issues directly associated with the stability failure,” U.S. Food and Drug Administration said in a recall notice on its website.
The raw material used to produce Thymoglobulin was considered the cause of change in the shelf life of the drug.
Additional lots, manufactured with comparable quality of the raw material, are also being recalled due to the potential risk of a stability failure.
Shares of France-based Sanofi were trading slightly down at 65.31 euros on Tuesday.