Why it was recalled
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Product description
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42
Lot numbers, UPCs & expiration codes
Lot #: 8M17C1, Exp 11/30/2020; 9E30C1, Exp 4/30/2021; 9F05C1, Exp 4/30/2021
Where it was sold
U.S.A. Nationwide
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-1322-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 28, 2020
- FDA report date
- Jun 24, 2020
- Quantity
- 119,364 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
Original FDA data
Every field from FDA enforcement report D-1322-2020, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85755
- Address
- 184 Liberty Corner Rd
- Code information
- Lot #: 8M17C1, Exp 11/30/2020; 9E30C1, Exp 4/30/2021; 9F05C1, Exp 4/30/2021
- Postal code
- 07059-6796
- Report date
- Jun 24, 2020
- Product type
- Drugs
- Recall number
- D-1322-2020
- Classification
- Class II
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
- Product quantity
- 119,364 bottles
- Termination date
- Jan 24, 2022
- Reason for recall
- Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- May 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2020