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Recall Observatory FDA recall evidence

Drug 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

D-1324-2020

May 28, 2020

Class II

Product summary

Firm
Glaxosmithkline Consumer Healthcare Holdings
Event
Event 85755
Status
Terminated
Classification
Class II
Quantity
629,796 bottles
Official record key
drug-enforcement:D-1324-2020

Official wording

Reason: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Code information: 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

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.