FDA Drug · D-0804-2018

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

Class II · Terminated

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

Affected lots / codes — check yours against thisLot #: 7F307A, 7F307C, Exp 01/2019

Recalling firm: Sanofi-Aventis U.S. LLC, Bridgewater, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 19580 vials
Distribution: US nationwide
Recall initiated: April 27, 2018
Classified: May 14, 2018
Terminated: January 20, 2021
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0804-2018%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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