Recall: D-0804-2018

Class II - Potentially Harmful

Class IIClassification
2018-04-27Initiated
TerminatedStatus
Sanofi-Aventis U.S. LLCFirm

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

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

Distribution

US nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.