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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

Product Description Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
Recall Number D-1408-2012
Classification Class II
Code Info Lot number and expiration dates Eloxatin® (OXALIplatin injection) 100mg vial AD21 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AD22 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AE24 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AE25 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF55 02/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AE26 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF03 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF04 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial AF21 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BL19B 03/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CB11B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CB102B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CB12B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CA01B 04/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BH07 06/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BH08 06/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial BH09 06/ 2012 Eloxatin® (OXALIplatin injection) 100mg vial CC109B 01/ 2014
Product Distributed Qty 387,738 vials
Reason For Recall CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

Event Detail

Event Id 62350
Product Type Drugs
Status Ongoing
Recalling Firm sanofi-aventis US, Inc.
City Bridgewater
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide.
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