April 2018 FDA Recall Docetaxel by Sanofi-aventis U.s. Llc
D-0804-2018 - Superpotent drug
This Class II drug recall was voluntarily initiated by Sanofi-aventis U.s. Llc on April 27, 2018 for the product Docetaxel. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0804-2018
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
04-27-2018
05-09-2018
19580 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sanofi-Aventis U.S. LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US nationwide
01-20-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : 7F307A, 7F307C, Exp 01/2019
