FDA recall D-0926-2017

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-06-12

Report date

2017-07-05

Termination date

2019-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0926-2017