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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-2/11/08

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.

 

Contact FDA

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

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448