Recalls / Class II
Class IID-0804-2018
Product
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
- Brand name
- Docetaxel
- Generic name
- Docetaxel
- Active ingredient
- Docetaxel
- Route
- Intravenous
- NDCs
- 0955-1020, 0955-1021, 0955-1022
- FDA application
- NDA020449
- Affected lot / code info
- Lot #: 7F307A, 7F307C, Exp 01/2019
Why it was recalled
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, N/A, Bridgewater, New Jersey 08807-1265
Distribution
- Quantity
- 19580 vials
- Distribution pattern
- US nationwide
Timeline
- Recall initiated
- 2018-04-27
- FDA classified
- 2018-05-14
- Posted by FDA
- 2018-05-09
- Terminated
- 2021-01-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0804-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.