Sanofi Recalls Over-Concentrated Docetaxel Injection Vials Nationwide
Sanofi-Aventis is recalling 19,580 vials of Docetaxel injection concentrate due to potential over-concentration. The affected lots were distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a superpotent drug with a risk of over-concentration, which aligns with the rubric criterion for Severe severity (FDA Class II with potential for significant harm).
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling 19,580 vials of Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only. The recall is due to a report that some vials may have been over-concentrated. The affected product is identified by Lot # 7F307A and 7F307C, with an expiration date of 01/2019.
The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The product was distributed nationwide. Docetaxel is a prescription medication administered intravenously.
Healthcare providers and patients should stop using the affected lots and contact Sanofi-Aventis for further instructions. Consumers should not use the recalled product and should consult their healthcare provider if they have already received the medication.
The recalled product
- Product
- DOCETAXEL (DOCETAXEL)
- Brand
- DOCETAXEL
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Category
- Drug — Prescription Injection
- Affected units
- 19,580
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 7F307A
- 7F307C
- Exp 01/2019
Distribution
Distributed nationwide across the United States.
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