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Recall Observatory FDA recall evidence

Drug product

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.

D-0563-2023

March 31, 2023

Class II

Product summary

Firm
Family Dollar Stores, Llc.
Event
Event 92248
Status
Ongoing
Classification
Class II
Quantity
Pending.
Official record key
drug-enforcement:D-0563-2023

Official wording

Reason: CGMP deviation: product outside labeled storage temperature requirements.

Code information: SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviation