Vaccines, Blood & Biologics

Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial

DATE RECALL INITIATED: August 2, 2012

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial

Lot Number Expiration Date
C0062C01 Dec 2012
C0072C01 Feb 2013
C0086C01 May 2013
C0094C01 July 2013
C0096C01 Aug 2013
C0098C01 Aug 2013
C0098C02 Aug 2013
C0098C03 Aug 2013
C0100C01 Aug 2013

MANUFACTURER:

Genzyme Corporation
A Sanofi Company
Framingham, MA

REASON:

Genzyme is initiating a voluntary recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial. This recall was initiated when one Thymoglobulin lot (C0072) 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 of the atypical stability trend, are being recalled based on the potential risk for a stability failure prior to end of shelf life for aggregation. No other Thymoglobulin lots are involved in this recall.

Genzyme has not identified any new safety risk to patients who have received Thymoglobulin from the implicated lot numbers, and there are no confirmed safety issues directly associated with the stability failure.


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.

Page Last Updated: 08/21/2014
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