D-1323-2020 Class II Terminated
FDA drug recall D-1323-2020 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: 151,344 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
- 151,344 bottles
Product description
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
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 #: 8H21C1, Exp 7/31/2020; 9B25C1, Exp 1/31/2021; 9D02C1, Exp 2/28/2021; 9G01C1, Exp 5/31/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1323-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026