Why it was recalled
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Product 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
Lot numbers, UPCs & expiration codes
Lot#: KH5L, Exp. Date 09/30/2027
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0079-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Dec 2, 2022
- FDA report date
- Nov 8, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline Consumer Healthcare Holdings LLC
Original FDA data
Every field from FDA enforcement report D-0079-2024, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Completed
- Country
- United States
- Event ID
- 93255
- Address
- 320 S Broadway
- Code information
- Lot#: KH5L, Exp. Date 09/30/2027
- Postal code
- 63102-2800
- Report date
- Nov 8, 2023
- Product type
- Drugs
- Recall number
- D-0079-2024
- Classification
- Class II
- Recalling firm
- GlaxoSmithKline Consumer Healthcare Holdings LLC
- Reason for recall
- Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 2, 2022
- Initial firm notification
- Letter
- Center classification date
- Oct 27, 2023