Aug 28 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.