Genzyme voluntarily recalls transplant rejection treatment

April 11, 2008 — /ROCKVILLE, MD/ — According to the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research web site, as of April 9, Genzyme Corp. (Cambridge, MA), Genzyme Europe B.V., and Genzyme Polyclonals, S.A.S. (Lyons, France) are initiating a voluntary recall of three finished product lots of Thymoglobulin (anti-thymocyte globulin (rabbit) 25 mg/vial): C7014C01, C7008C01, and TH175-05.

FDA’s site states that “[t]his recall was initiated when Thymoglobulin lot C7014C01 failed a periodic stability test based upon appearance of the reconstituted product. Reconstituted solution from lot C7014C01 initially passed this stability test prior to market release. The specification for the appearance of reconstituted Thymoglobulin solution is a clear, limpid to slightly opalescent liquid. Samples from lot C7014C01 have recently exceeded the slightly opalescent stability specification based upon visual examination of the reconstituted product. The two additional lots involved in this recall, lot numbers TH175-05 and C7008C01, are being recalled based on a predicted stability failure for appearance prior to the labeled expiration dates. Customers are asked to immediately discontinue all use of these lots and to return all Thymoglobulin vials to Genzyme Corp.”

Thymoglobulin is a sterile lyophilized drug manufactured from rabbit proteins given via injection to kidney transplant recipients in order to treat organ rejection.

On February 29, FDA also posted a voluntary recall notice regarding lot number CG024CAA of the drug with the same reasons for recall specified.

Source: FDA


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