Home / Recalls / Sanofi-Aventis U.S. LLC / D-0926-2017

D-0926-2017 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
July 5, 2017
Initiation Date
June 12, 2017
Termination Date
February 7, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2980 bottles

Product Description

Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.

Reason for Recall

Superpotent Drug: high out-of-specification result for magnesium.

Distribution Pattern

Nationwide in the USA, Puerto Rico, and the United Kingdom.

Code Information

Lot #: 5J69A, Exp 02/19; 6GF2A, 6GF3A, Exp 08/19

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)