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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Detail

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

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 Letter
Distribution Pattern Nationwide