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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Event Detail

Event ID 65959
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA, Inc.
City Sellersville
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11 Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14 Class II Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer. 780 vials D-928-2013