sanofi-aventis US, Inc.: 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.

Agency Publication Date: July 5, 2012

Affected Products

Product: 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

Lot Numbers:

number

Product: 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

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62350

Status: Resolved

Manufacturer: sanofi-aventis US, Inc.

Manufactured In: United States

Units Affected: 2 products (196,355 vials; 387,738 vials)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: 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 Numbers:

number

Product: 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 Numbers:

number