CALCIUM CARBONATE Recall D-0074-2024
Description: TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5
CALCIUM CARBONATE Recall D-0074-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0074-2024 |
| 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 | 307660746805 |
| 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 |
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