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Recall Observatory FDA recall evidence

Drug product

PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00

D-0493-2022

January 24, 2022

Class II

Product summary

Firm
Ultra Seal Corporation
Event
Event 89464
Status
Terminated
Classification
Class II
Quantity
111,300 packets
Official record key
drug-enforcement:D-0493-2022

Official wording

Reason: cGMP deviations

Code information: Lot #: AK9698, Exp. Date 07/2022

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations