BETHESDA, MD 30 August 2012—Genzyme has recalled nine lots of Thymoglobulin because of concerns about stability test results, according to an announcement at FDA's website.
According to the announcement, which is dated August 2, one lot of Thymoglobulin did not perform as expected during a periodic stability test for molecular size distribution. That lot and eight others derived from raw materials with similar quality characteristics are subject to the recall.
The recalled lots are C0062C01, with a labeled expiration date of December 2012; C0072C01 (expiration date February 2013); C0086C01 (an expiration date May 2013); C0094C01 (expiration date July 2013); and C0096C01, C0098C01, C0098C02, C0098C03, and C0100C01, all of which expire in August of 2013.
The company stated that it has not identified a new safety risk to patients treated with the recalled lots, and no safety issues directly associated with the stability failure have been reported.
Thymoglobulin antithymocyte globulin (rabbit) is part of an immunosuppressive regimen to prevent organ rejection in patients who have undergone kidney transplantation.