Drug product
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
D-1323-2020
Product summary
- Event
- Event 85755
- Status
- Terminated
- Classification
- Class II
- Quantity
- 151,344 bottles
- Official record key
drug-enforcement:D-1323-2020
Official wording
Reason: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Code information: Lot #: 8H21C1, Exp 7/31/2020; 9B25C1, Exp 1/31/2021; 9D02C1, Exp 2/28/2021; 9G01C1, Exp 5/31/2021
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.