Home / Recalls / Sanofi-Aventis U.S. LLC / D-0575-2023

D-0575-2023 Class II Ongoing

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

Recall Details

Product Type
Drugs
Report Date
May 24, 2023
Initiation Date
April 11, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
51,325 vials

Product Description

Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05

Reason for Recall

Lack of Assurance of Sterility: Malformed crimped collar seal

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 3F497B, EXP 12-31-2025

Other recalls by Sanofi-Aventis U.S. LLC

  • D-1507-2020 Class II — Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventi (August 10, 2020)
  • D-0545-2020 Class II — Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Cha (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-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-0536-2020 Class II — Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0541-2020 Class II — Regular 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-0539-2020 Class II — Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company (October 22, 2019)
  • D-0534-2020 Class II — Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, (October 22, 2019)