Drug product
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.
D-0926-2017
Product summary
- Event
- Event 77478
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2980 bottles
- Official record key
drug-enforcement:D-0926-2017
Official wording
Reason: Superpotent Drug: high out-of-specification result for magnesium.
Code information: Lot #: 5J69A, Exp 02/19; 6GF2A, 6GF3A, Exp 08/19
Distribution pattern: Nationwide in the USA, Puerto Rico, and the United Kingdom.
Derived failure modes
-
Potency or specification failure
Superpotent