D-0077-2024 Class II
FDA drug recall D-0077-2024 was initiated by GlaxoSmithKline Consumer Healthcare Holdings LLC on Dec 2, 2022 and is designated Class II. Reason for recall: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 8, 2023
- Initiation Date
- Dec 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Reason for recall
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Distribution pattern
Nationwide within the United States
Code information
Lot#: HR6A, Exp. Date 09/30/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0077-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026