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Recall Observatory FDA recall evidence

Drug product

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles

D-0565-2023

March 31, 2023

Class II

Product summary

Firm
Family Dollar Stores, Llc.
Event
Event 92248
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0565-2023

Official wording

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

Code information: SKUs 0902867 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