FDA Recall D-0181-2023
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon · Warren, NJ
Class I — life-threatening Terminated 447 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Recall record
- Recall number
D-0181-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2022-12-06
- Classified by FDA Center
- 2023-01-25
- FDA published
- 2023-02-01
- Terminated
- 2024-02-26
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
- Firm location
- Warren, NJ