Recalls / Class II
Class IID-1323-2020
Product
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
- Brand name
- Gaviscon
- Generic name
- Aluminum Hydroxide And Magnesium Carbonate
- Active ingredients
- Aluminum Hydroxide, Magnesium Carbonate
- Route
- Oral
- NDCs
- 0135-0094, 0135-0095, 0135-0574
- FDA application
- M001
- Affected lot / code info
- Lot #: 8H21C1, Exp 7/31/2020; 9B25C1, Exp 1/31/2021; 9D02C1, Exp 2/28/2021; 9G01C1, Exp 5/31/2021
Why it was recalled
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Recalling firm
- Firm
- Glaxosmithkline Consumer Healthcare Holdings
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 184 Liberty Corner Rd, Warren, New Jersey 07059-6796
Distribution
- Quantity
- 151,344 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-05-28
- FDA classified
- 2020-06-18
- Posted by FDA
- 2020-06-24
- Terminated
- 2022-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1323-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.