Recall
Thymoglobulin
DATE RECALL INITIATED:
August 22 , 2008
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25 mg/vial
NDC# 58468-0080-1
Lot Number: C7010C01
Expiration Date: April 2010
MANUFACTURER:
Genzyme Corporation
Framingham, Massachusetts
REASON:
Genzyme Corporation and Genzyme Polyclonals, S.A.S. are initiating a recall of one Thymoglobulin finished product lot based on visual inspection results on stability. Lot number C7010C01 is being recalled due to an out of specification result during stability testing for the appearance referred to as opalescence. Consignees have been asked to contact the manufacturer to arrange for product return.
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.