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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
Related recalls
Same brand · DOCETAXEL
- CriticalDocetaxel Injection Recalled Nationwide for Stopper Particulate Matter
FDA (Drugs) · 2024-06-19
- SevereDocetaxel Injection Recalled Due to Particulate Matter in Stopper
FDA (Drugs) · 2024-06-19
- SevereDr. Reddy's Recalls Docetaxel Injection Due to Vial Seal and Cap Defects
FDA (Drugs) · 2019-03-20
- ModerateDr. Reddy's Recalls Docetaxel Injection Vials Due to Seal Defects
FDA (Drugs) · 2018-01-17
Same manufacturer · Sanofi-Aventis U.S. LLC
See all →- HighADMELOG Insulin Lispro Recalled for Malformed Seal Defect
FDA (Drugs) · 2023-05-24
- ModerateSanofi Recalls Elitek (Rasburicase) Vials Due to Stability Testing Failures
FDA (Drugs) · 2020-08-26
- SevereSanofi Recalls Zantac Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereSanofi Recalls Regular Strength Zantac 75 mg Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereSanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-12-11