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Recall Observatory FDA recall evidence

Drug product

Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41

D-1325-2020

May 28, 2020

Class II

Product summary

Firm
Glaxosmithkline Consumer Healthcare Holdings
Event
Event 85755
Status
Terminated
Classification
Class II
Quantity
1,631,700 bottles & 27,300 Twin-Pack botles
Official record key
drug-enforcement:D-1325-2020

Official wording

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

Code information: Lot #: 0A21C1, Exp 12/31/2021; 0A31C1, Exp 12/31/2021; 0B05C1, Exp 12/31/2021; 8J04C1, Exp 7/31/2020; 8L05C1, Exp 9/30/200; 8L13C1 , Exp 10/31/2020; 9A14C1, Exp 12/31/2020; 9A21C1, Exp 12/31/2020; 9B04C1, Exp 12/31/2020; 9B11C1, Exp 1/31/2021; 9C04C1, Exp 1/31/2021; 9C12C1, Exp 2/28/2021; 9C25C1, Exp 2/28/2021; 9D17C1, Exp 3/312021; 9D24C1, Exp 3/312021; 9E01C1, Exp 3/31/2021; 9E10C1, Exp 3/31/2021; 9E21C1, Exp 4/30/2021; 9F11C1, Exp 5/31/2021; 9G15C1, Exp 6/30/2021; 9G30C1, Exp 6/30/2021; 9H06C1, Exp 6/30/2021; 9H12C1, Exp 7/31/2021, 9H2OC1, Exp 7/31/2021; 9H26C1, Exp 7/31/2021; 9J23C1, Exp 8/31/2021; 9J3OC1, Exp 8/31/2021; 9K08C1, Exp 8/31/2021; 9L11C1, Exp 10/31/2021; 9L18C1, Exp 10/31/2021; 9M02C1, Exp 10/31/2021; 9M09C1, Exp 11/30/2021; 9M17C1, Exp 11/30/2021; 19N1587221, Exp 7/31/2020; 19N1743754, Exp 12/31/2020; 19N1948440, Exp 6/30/2021; 19N1958219, Exp 6/30/2021; 20N2019997, Exp 7/31/2021; 20N2026258, Exp 8/31/2021; 20N2057778, Exp 8/31/2021

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.