Recalls / Class II
Class IID-0075-2024
Product
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2
- Brand name
- Tums
- Generic name
- Calcium Carbonate
- Active ingredient
- Calcium Carbonate
- Route
- Oral
- NDCs
- 0135-0118, 0135-0180, 0135-0181, 0135-0228, 0135-0540
- FDA application
- M001
- Affected lot / code info
- Lot #: HV6B, Exp. Date 9/30/2027
Why it was recalled
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recalling firm
- Firm
- GlaxoSmithKline Consumer Healthcare Holdings LLC
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 320 S Broadway, N/A, Saint Louis, Missouri 63102-2800
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-12-02
- FDA classified
- 2023-10-27
- Posted by FDA
- 2023-11-08
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0075-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.