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

FDA recall notice · announced May 9, 2018 · Sanofi-aventis U.s

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.

Notes

Distribution: US nationwide
Lot/code information: Lot #: 7F307A, 7F307C, Exp 01/2019
Quantity: 19580 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.