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Class II: temporary or reversible health riskTerminated

Glaxosmithkline Consumer Healthcare Holdings Gaviscon Extra Strength Liquid Antacid Extra Recall

Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ

Glaxosmithkline Consumer Healthcare Holdings · Warren, NJ

Risk level
Class II
Reported by FDA
Jun 24, 2020
Recall ID
D-1324-2020
Check your lot numberHow we source this data

Summary

Glaxosmithkline Consumer Healthcare Holdings recalled Gaviscon Extra Strength Liquid Antacid Extra starting May 28, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1324-2020 on Jun 24, 2020. Reason: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

U.S.A. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1324-2020
Classification
Class II
Status
Terminated
Recall initiated
May 28, 2020
FDA report date
Jun 24, 2020
Quantity
629,796 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Glaxosmithkline Consumer Healthcare Holdings

Original FDA data

Every field from FDA enforcement report D-1324-2020, exactly as published.

Show all FDA fields
City
Warren
State
NJ
Status
Terminated
Country
United States
Event ID
85755
Address
184 Liberty Corner Rd
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
Postal code
07059-6796
Report date
Jun 24, 2020
Product type
Drugs
Recall number
D-1324-2020
Classification
Class II
Recalling firm
Glaxosmithkline Consumer Healthcare Holdings
Product quantity
629,796 bottles
Termination date
Jan 24, 2022
Reason for recall
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
U.S.A. Nationwide
Recall initiation date
May 28, 2020
Initial firm notification
Letter
Center classification date
Jun 18, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1324-2020, published Jun 24, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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