Recalls / Class II
Class IID-1324-2020
Product
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41
- Affected lot / code info
- Lot #: 0A26C1, Exp 12/31/2021; 0B10C1, Exp 1/31/2022; 8L19C1, Exp 10/31/2020; 8L27C1, Exp 10/31/2020; 9A28C1, Exp 12/31/2020; 9B18C1, Exp 1/31/2021; 9C19C1, Exp 2/28/2021; 9D09C1, Exp 3/31/2021; 9F20C1, Exp 5/31/2021; 9G24C1, Exp 6/30/2021; 9J09C1, Exp 8/31/2021; 9K29C1, Exp 9/30/2021; 9L05C1, Exp 9/30/2021
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
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 184 Liberty Corner Rd, Warren, New Jersey 07059-6796
Distribution
- Quantity
- 629,796 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-1324-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.