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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]-Genzyme Corporation

DATE RECALL INITIATED:

April 9, 2008

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Anti-thymocyte Globulin (Rabbit) 25 mg/vial
NDC # 58468-0080-1
Lot Numbers: C7014C01 (Expires May 31, 2010)
                          C7008C01 (Expires March 31, 2010)
                          TH175-05 (Expires October 4, 2009)

MANUFACTURER:

Genzyme Corporation
Framingham, Massachusetts

REASON:

Genzyme Corporation , Genzyme Europe B.V., and Genzyme Polyclonals, S.A.S. are initiating a voluntary recall of Thymoglobulin finished product lots: C7014C01, C7008C01, and TH175-05. This 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 2 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 Corporation.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

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Food and Drug Administration

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Suite 200N/HFM-47

Rockville, MD 20852-1448