FDA recall D-0077-2024

GlaxoSmithKline Consumer Healthcare Holdings LLC · Class II · drug

Product

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6

Reason for recall

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Distribution

Nationwide within the United States

Key facts

Status: Completed
Initiation date: 2022-12-02
Report date: 2023-11-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0077-2024