FDA recall D-0804-2018

Sanofi-Aventis U.S. LLC · Class II · 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

Reason for recall

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

Distribution

US nationwide

Key facts

Status
Terminated
Initiation date
2018-04-27
Report date
2018-05-09
Termination date
2021-01-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0804-2018