D-1324-2020 Class II Terminated
FDA drug recall D-1324-2020 was initiated by Glaxosmithkline Consumer Healthcare Holdings on May 28, 2020 and is designated Class II. Reason for recall: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. The recall status is terminated (terminated Jan 24, 2022). Affected quantity: 629,796 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 24, 2020
- Initiation Date
- May 28, 2020
- Termination Date
- Jan 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 629,796 bottles
Product description
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41
Reason for recall
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Distribution pattern
U.S.A. Nationwide
Code information
Lot #: 0A26C1, Exp 12/31/2021; 0B10C1, Exp 1/31/2022; 8L19C1, Exp 10/31/2020; 8L27C1, Exp 10/31/2020; 9A28C1, Exp 12/31/2020; 9B18C1, Exp 1/31/2021; 9C19C1, Exp 2/28/2021; 9D09C1, Exp 3/31/2021; 9F20C1, Exp 5/31/2021; 9G24C1, Exp 6/30/2021; 9J09C1, Exp 8/31/2021; 9K29C1, Exp 9/30/2021; 9L05C1, Exp 9/30/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1324-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026