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FDA (Drug enforcement)Recalled 2020-05-28closedclass ii

Glaxosmithkline Consumer Healthcare Holdings: 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,

Is my product affected?

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

  • Brand GAVISCON

Check against the official notice below — it lists the full affected range.

What happened

GlaxoSmithKline Consumer Healthcare is recalling Gaviscon Liquid Antacid Extra Strength in Cool Mint flavor (12 FL OZ bottles in single and twin packs) distributed nationwide. The recall affects approximately 1.6 million individual bottles and 27,300 twin-pack bottles due to missing safety warnings on the label. Specifically, the bottle label does not include a required warning about magnesium safety. The recalled products include multiple lot codes with expiration dates ranging from July 2020 through December 2021.

The recall notice does not specify a remedy or instructions for what consumers should do with affected bottles.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Distribution: U.S.A. Nationwide Quantity: 1,631,700 bottles & 27,300 Twin-Pack botles Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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