FDA recall D-1322-2020

Glaxosmithkline Consumer Healthcare Holdings · Class II · 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

Reason for recall

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Distribution

U.S.A. Nationwide

Key facts

Status
Terminated
Initiation date
2020-05-28
Report date
2020-06-24
Termination date
2022-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1322-2020