Recall
Thymoglobulin
DATE RECALL INITIATED:
February 11, 2008
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial
NDC# 58468-0080-1
Lot Number: CG024CAA
Expiration Date: Nov 2009
MANUFACTURER:
Genzyme Corporation
Framingham, Massachusetts
REASON:
Genzyme Corporation and Genzyme Polyclonals, S.A.S. are voluntarily recalling Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg vials, labeled as lot number CG024CAA. No other Thymoglobulin lots are involved in this recall. This recall was initiated when Thymoglobulin, lot CG024CAA failed a periodic stability test based upon appearance of the reconstituted product. Reconstituted solution from this lot 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 this lot have recently exceeded the slightly opalescent stability specification based upon visual examination of the reconstituted product. Customers are asked to immediately discontinue all use of Thymoglobulin lot CG024CAA and to return all Thymoglobulin vials to Genzyme Corporation.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.