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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
Recall Number D-139-2013
Classification Class II
Code Info Lot: 0NCW005, Exp 02/2013
Product Distributed Qty 17,169 Packages
Reason For Recall Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.

Event Detail

Event Id 63879
Product Type Drugs
Status Ongoing
Recalling Firm Schering-Plough Products, LLC
City Las Piedras
State PR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico