D-0181-2023 Class I Terminated
FDA drug recall D-0181-2023 was initiated by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon on December 6, 2022 and is designated Class I. Reason for recall: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back The recall status is terminated (terminated February 26, 2024). Affected quantity: 321,246 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- February 1, 2023
- Initiation Date
- December 6, 2022
- Termination Date
- February 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 321,246 tablets
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
Reason for Recall
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Distribution Pattern
Nationwide in the USA.
Code Information
a) Lots EJ2218, EJ2219, EJ2220, Exp 09/2023; b) Lot 953D, Exp 05/2025