TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist.
Summary
The FDA issued a Class II for TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable T by GlaxoSmithKline Consumer Healthcare Holdings LLC. Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool..
Details
Source
Drug Recall
External ID
D-0077-2024
Action Date
2023-11-08
Status
Completed
Category
drug
Product Description
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
Lot/Code Info: Lot#: HR6A, Exp. Date 09/30/2027
Quantity Affected: N/A
Reason for Recall
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-02
Company
Saint Louis, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 33 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
GlaxoSmithKline Consumer Healthcare Holdings LLC has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GlaxoSmithKline Consumer Healthcare Holdings LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GlaxoSmithKline Consumer Healthcare Holdings LLC have FDA actions?
GlaxoSmithKline Consumer Healthcare Holdings LLC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0077-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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