Drug product
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42
D-1322-2020
Product summary
- Event
- Event 85755
- Status
- Terminated
- Classification
- Class II
- Quantity
- 119,364 bottles
- Official record key
drug-enforcement:D-1322-2020
Official wording
Reason: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Code information: Lot #: 8M17C1, Exp 11/30/2020; 9E30C1, Exp 4/30/2021; 9F05C1, Exp 4/30/2021
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.