Sanofi Recalls Eloxatin Injection Due to Manufacturing Practice Deviations
Sanofi-aventis is recalling 196,355 vials of Eloxatin (oxaliplatin) injection nationwide because the contract manufacturer failed to meet Good Manufacturing Practices.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations without reported illnesses or injuries, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Sanofi-aventis US, Inc. is recalling 196,355 vials of Eloxatin (oxaliplatin injection) 5 mg/mL, 50 mg, Rx only. The product is distributed nationwide. The recall is being conducted because 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.
The affected lots include AE41, CA02B, AE27, BL18B, CB13B, CD65B, and CE39B, with expiration dates ranging from 02/2012 to 01/2014. The source text does not specify reported illnesses, injuries, or deaths associated with these specific lots.
Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- 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
- Manufacturer
- sanofi-aventis US, Inc.
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 196,355
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by sanofi-aventis US, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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