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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10 Lot number and expiration dates Eloxatin® (OXALIplatin injection) 50mg vial AE41 02/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial CA02B 02/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial AE27 02/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial BL18B 06/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial CB13B 06/ 2012 Eloxatin® (OXALIplatin injection) 50mg vial CD65B 01/ 2014 Eloxatin® (OXALIplatin injection) 50mg vial CE39B 01/ 2014 Class II 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. 196,355 vials D-1407-2012
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20 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 Class II 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. 387,738 vials D-1408-2012
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