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Recall Observatory FDA recall evidence

Drug product

Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124

D-0507-2022

January 24, 2022

Class II

Product summary

Firm
Ultra Seal Corporation
Event
Event 89464
Status
Terminated
Classification
Class II
Quantity
1,1401,641 packets
Official record key
drug-enforcement:D-0507-2022

Official wording

Reason: cGMP deviations

Code information: Lot #: AK9796, Exp. Date 09/2022

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations