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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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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
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot: 0NCW005, Exp 02/2013 Class II 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. 17,169 Packages D-139-2013