FDA Drug Class III — Least Serious

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.

Hazard

Superpotent Drug: high out-of-specification result for magnesium.

Products

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,
Brand
Sanofi-Aventis U.S. LLC
UPC
Lot #: 5J69A, Exp 02/19; 6GF2A, 6GF3A, Exp 08/19

Units Affected

2980 bottles