Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UP
Summary
The FDA issued a Class I for Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon. Reason: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back.
Details
Source
Drug Recall
External ID
D-0181-2023
Action Date
2023-02-01
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: a) Lots EJ2218, EJ2219, EJ2220, Exp 09/2023; b) Lot 953D, Exp 05/2025
Quantity Affected: 321,246 tablets
Reason for Recall
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-06
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Glaxosmithkline Consumer Healthcare Holdings DBA Haleon) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glaxosmithkline Consumer Healthcare Holdings DBA Haleon have FDA actions?
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0181-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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