Drug 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
D-0804-2018
Product summary
- Event
- Event 79964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19580 vials
- Official record key
drug-enforcement:D-0804-2018
Official wording
Reason: Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Code information: Lot #: 7F307A, 7F307C, Exp 01/2019
Distribution pattern: US nationwide
Derived failure modes
-
Potency or specification failure
Superpotent