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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Genzyme Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)], 25 mg, for intravenous use only, Rx. NDC 58468-0080-01
Recall Number B-0964-13
Classification Class II
Code Info C0072C01 Feb 2013; C0062C01 Dec 2012; C0086C01 May 2013; C0094C01 Jul 2013; C0096C01 Aug 2013; C0098C01 Aug 2013; C0098C02 Aug 2013; C0098C03 Aug 2013; C0100C01 Aug-2013
Product Distributed Qty 9 units
Reason For Recall Anti-Thymocyte Globulin (Rabbit) 25 mg, with an OOS assay result on the molecular size distribution stability test, was distributed.

Event Detail

Event Id 62670
Product Type Biologics
Status Ongoing
Recalling Firm Genzyme Corporation
City Framingham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide