Key Takeaway

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, by Sanofi-Aventis U.S. LLC was recalled on June 12, 2017. The hazard: Superpotent Drug: high out-of-specification result for magnesium.

FDA Drug Class III Terminated

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,

Recalled: June 12, 2017 ~2980 bottles units affected D-0926-2017

Description

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 / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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,

Drugs

Company Information

Sanofi-Aventis U.S. LLC

Bridgewater, NJ, United States

View all 22 recalls by Sanofi-Aventis U.S. LLC →

Distribution

Nationwide in the USA, Puerto Rico, and the United Kingdom.

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Frequently Asked Questions

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

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Where can I find the original recall notice?

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