Drug Enforcement D-0078-2024

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

Status

Completed

Classification

Class II

Report Date

November 8, 2023

Termination Date

Product Information

Product description
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
Product quantity
N/A
Reason for recall
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
GlaxoSmithKline Consumer Healthcare Holdings LLC
Address
320 S Broadway, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0078-2024
Event ID
93255
Recall initiation date
December 2, 2022
Center classification date
October 27, 2023
Code info
Lot #: J96X,J96W, Exp. Date 09/30/2027
More code info