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Recall Observatory FDA recall evidence

Drug product

Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.

D-0566-2023

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-0566-2023

Official wording

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

Code information: SKUs a) 0999841; b) 0916071 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