FDA recall D-1325-2020

Product

Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41

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-1325-2020