Multi-event May 2020 FDA Recall Gaviscon by Glaxosmithkline Consumer Healthcare Holdings
This Multi-event Class II drug recall was voluntarily initiated by Glaxosmithkline Consumer Healthcare Holdings on May 28, 2020 for the product Gaviscon. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1324-2020
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
05-28-2020
06-24-2020
629,796 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
01-24-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration 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
Recall Number: D-1322-2020
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
05-28-2020
06-24-2020
119,364 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
01-24-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42
Batch or Lot Expiration Information
Lot# : 8M17C1, Exp 11/30/2020; 9E30C1, Exp 4/30/2021; 9F05C1, Exp 4/30/2021
Affected Packages Involved in this Recall
Recall Number: D-1323-2020
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
05-28-2020
06-24-2020
151,344 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
01-24-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
Batch or Lot Expiration Information
Lot# : 8H21C1, Exp 7/31/2020; 9B25C1, Exp 1/31/2021; 9D02C1, Exp 2/28/2021; 9G01C1, Exp 5/31/2021
Affected Packages Involved in this Recall
Recall Number: D-1325-2020
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
05-28-2020
06-24-2020
1,631,700 bottles & 27,300 Twin-Pack botles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
01-24-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration 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
