Drug Enforcement D-1408-2012

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.

Status

Terminated

Classification

Class II

Report Date

July 11, 2012

Termination Date

December 3, 2013

Product Information

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
Product quantity
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide.

Location & Firm

Recalling firm
sanofi-aventis US, Inc.
Address
Route 202-206, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-1408-2012
Event ID
62350
Recall initiation date
February 6, 2012
Center classification date
July 5, 2012
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
More code info
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