CLASS II Drug recall · Reported 11 Jul 2012 · FDA Enforcement Report
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg recalled
sanofi-aventis US is recalling Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, distributed nationwide in the US. The recall was initiated on 6 Feb 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1408-2012
- FDA event ID
- 62350
- Recalling firm
- sanofi-aventis US, Bridgewater, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Feb 2012
- FDA classified
- 5 Jul 2012
- Reported
- 11 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Feb 2012 | Recall initiated by company | |
| 5 Jul 2012 | Classified by FDA | +150 days |
| 11 Jul 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 62350This product is part of a recall event; the main page for the event is Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg recalled | sanofi-aventis US | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from sanofi-aventis US
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Diamigo i-Phone App The Diamigo app was intended recalled | sanofi-aventis US | Device Malfunction | NJ |
| Drug | CLASS II | Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg recalled | sanofi-aventis US | Manufacturing (CGMP) Deviations | Nationwide |
Other Eloxatin (oxaliplatin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg recalled | sanofi-aventis US | Manufacturing (CGMP) Deviations | Nationwide |