CALCIUM CARBONATE Recall D-0079-2024
Description: TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8
CALCIUM CARBONATE Recall D-0079-2024 Information
Status | Completed |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0079-2024 |
Event ID | 93255 |
Brand | TUMS |
Generic Name | CALCIUM CARBONATE |
Manufacturer | CALCIUM CARBONATE |
Original Package? | 1 |
Active Substance | CALCIUM CARBONATE |
Drug Route | ORAL |
Distribution | Nationwide within the United States |
Recall Reason | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. |
Drug Classification | Class II |
Drug Code Info | 20231108 |
Product NDC | 0135-0118 0135-0180 0135-0181 |
Drug UPC | 307660746508 |
Recall Initiation Date | 20221202 |
Report Date | 20231108 |
Classification Date | 20231027 |
Address | 320 S Broadway Saint Louis, MO 63102-2800 United States |
Recalling Firm | GlaxoSmithKline Consumer Healthcare Holdings LLC |
Initial Notification | Letter |
Unique Ingredient Identifier | H0G9379FGK |
Drug Application Number | part331 |
Structured Product Labeling (SPL ID) | 3cc802ad-35d1-4f7c-8537-b542638ad603 |
Structured Product Labeling (SPL Set ID) | f4786707-a0f7-4ba8-9656-06278d1b4b6c |
Similar To |