BioCentury
ARTICLE | Company News

Sanofi sales and marketing update

September 3, 2012 7:00 AM UTC

FDA said Sanofi's Genzyme Corp. subsidiary recalled nine lots of Thymoglobulin after one lot of the renal transplant rejection drug failed a periodic stability test for the molecular size distribution test. Genzyme recalled the additional lots because they were manufactured with comparable quality of the raw material that is considered to be the root cause of the atypical stability trend. According to an FDA recall letter, Genzyme has not identified any new safety risk to patients who have received Thymoglobulin from the recalled lots and there are no confirmed safety issues directly associated with the stability failure. ...

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