Multi-event March 2020 FDA Recall Advil by Glaxosmithkline Consumer Healthcare Holdings
This Multi-event Class II drug recall was voluntarily initiated by Glaxosmithkline Consumer Healthcare Holdings on March 16, 2020 for the product Advil. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed throughout the United States, including Puerto Rico. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1068-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
03-16-2020
04-01-2020
566 blister packs
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.
Product was distributed throughout the United States, including Puerto Rico.
10-28-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
Batch or Lot Expiration Information
Lot# Batch/
Lot# 0045DB, exp. date 07/31/2021, original
Lot# R73995 9327VB, exp. date 07/31/2021, original
Lot# R73995 0017DA, exp. date 07/31/2021, original
Lot# R73995 9353WA, exp. date 07/31/2021, original
Lot# R73995
Recall Number: D-1069-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
03-16-2020
04-01-2020
4,104 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.
Product was distributed throughout the United States, including Puerto Rico.
10-28-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB
Batch or Lot Expiration Information
Lot# Batch/
Lot# 0198FR, original
Lot# R53074, exp. date 10/31/2020
Lot# 3188FRB, original
Lot# R53074, exp. date 10/31/2020
Recall Number: D-1067-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
03-16-2020
04-01-2020
151,056 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.
Product was distributed throughout the United States, including Puerto Rico.
10-28-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
Batch or Lot Expiration Information
Lot# Batch/
Lot# R73761, exp. date 01/31/2021, Item # F00573019175, 0.75 oz. R74936, exp. date 02/28/2021, Item # F00573019175, 0.75 oz. R56290, exp. date 03/31/2020, Item # F00573019150, 1 oz. R60959, exp. date 02/28/2021, Item # F00573019150, 1 oz. R78826, exp. date 11/30/2021, Item # F00573019150, 1 oz. 9335UA, exp. date 01/31/2021, item # F00573019175A - Co-package 9336UA, exp. date 02/28/2021, item # F00573019175A - Co-package
Affected Packages Involved in this Recall
Recall Number: D-1065-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
03-16-2020
04-01-2020
471,024 blisters
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.
Product was distributed throughout the United States, including Puerto Rico.
10-28-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister
Batch or Lot Expiration Information
Lot# Batch/Lot Numbers: R73995, exp. date 07/31/2021 R53915, exp. date 05/31/2020 9324HA, exp. date 07/31/2021 9327HA, exp. date 07/31/2021
Recall Number: D-1066-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
03-16-2020
04-01-2020
446,628 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.
Product was distributed throughout the United States, including Puerto Rico.
10-28-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
Batch or Lot Expiration Information
Lot# Batch/Lot Numbers: R53074, exp. date 10/31/2020, item # F00573176989, 160 ct. R53075, exp. date 10/31/2020, item # F00573176989, 160 ct. R53076, exp. date 11/30/2020, item # F00573176989, 160 ct. R53077, exp. date 11/30/2020, item # F00573176989, 160 ct. R53081, exp. date 11/30/2020, item # F00573176989, 160 ct. R53901, exp. date 02/28/2021, item # F00573176989, 160 ct. R53902, exp. date 03/31/2021, item # F00573176989, 160 ct. R62780, exp. date 06/30/2021, item # F00573176989, 160 ct.
