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Vaccines, Blood & Biologics

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

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.

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 06/27/2013
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