Home / Recalls / Sanofi-Aventis U.S. LLC / D-0804-2018

D-0804-2018 Class II Terminated

Recalled by Sanofi-Aventis U.S. LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
May 9, 2018
Initiation Date
April 27, 2018
Termination Date
January 20, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19580 vials

Product Description

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 Pattern

US nationwide

Code Information

Lot #: 7F307A, 7F307C, Exp 01/2019

Other recalls by Sanofi-Aventis U.S. LLC

  • D-0575-2023 Class II — Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx (April 11, 2023)
  • D-1507-2020 Class II — Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventi (August 10, 2020)
  • D-0536-2020 Class II — Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0544-2020 Class II — Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Ch (October 22, 2019)
  • D-0540-2020 Class II — Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0535-2020 Class II — Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0539-2020 Class II — Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company (October 22, 2019)
  • D-0537-2020 Class II — Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0545-2020 Class II — Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Cha (October 22, 2019)
  • D-0541-2020 Class II — Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company (October 22, 2019)