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Recall Observatory FDA recall evidence

Drug 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

D-0181-2023

December 06, 2022

Class I

Product summary

Firm
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon
Event
Event 91259
Status
Terminated
Classification
Class I
Quantity
321,246 tablets
Official record key
drug-enforcement:D-0181-2023

Official wording

Reason: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

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

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back