Multi-event December 2022 FDA Recall Drug by Glaxosmithkline Consumer Healthcare Holdings Dba Haleon

This Multi-event Class I drug recall was voluntarily initiated by Glaxosmithkline Consumer Healthcare Holdings Dba Haleon on December 6, 2022 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0181-2023 TERMINATED D-0183-2023 TERMINATED D-0182-2023 TERMINATED

Recall Number: D-0181-2023

Reason for Recall
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Initiated
12-06-2022
Reported
02-01-2023
Quantity
321,246 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91259
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-26-2024
Product Description About Product Description
Full technical description of the product.
Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940

Batch or Lot Expiration Information

Lot# a) Lots EJ2218, EJ2219, EJ2220, Exp 09/2023; b) Lot 953D, Exp 05/2025

Recall Number: D-0183-2023

Reason for Recall
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Initiated
12-06-2022
Reported
02-01-2023
Quantity
209,292 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91259
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-26-2024
Product Description About Product Description
Full technical description of the product.
Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5

Batch or Lot Expiration Information

Lot# Lot: R93517, R94072, R94073, Exp 02/29/2024; T00655, Exp 03/31/2025

Recall Number: D-0182-2023

Reason for Recall
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Initiated
12-06-2022
Reported
02-01-2023
Quantity
88,380 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91259
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-26-2024
Product Description About Product Description
Full technical description of the product.
Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3

Batch or Lot Expiration Information

Lot# Lot: R94065, Exp 02/29/2024