Genzyme initiated a voluntary recall of Thymoglobulin (anti-thymocyte globulin [rabbit] 25mg/vial) when one lot failed a periodic stability test for the molecular size distribution test. Additional lots, manufactured with comparable quality of the raw material considered to be the root cause, are being recalled based on potential risk for a stability failure prior to end of shelf life or aggregation.
The affected lot numbers and expiration dates include: C0062C01 (Dec 2012), C0072C01 (Feb 2013), C0086C01 (May 2013), C0094C01 (July 2013), C0096C01 (Aug 2013), C0098C01 (Aug 2013), C0098C02 (Aug 2013), C0098C03 (Aug 2013), and C0100C01 (Aug 2013).
Thymoglobulin, a gamma immune globulin, is indicated in the treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression. Genzyme has not identified any safety risk to patients who have received Thymoglobulin from the implicated lot numbers at this time.
For more information visit http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm317127.htm.