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Recall Observatory FDA recall evidence

Drug product

Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10

D-0729-2021

June 16, 2021

Class II

Product summary

Firm
Spirit Pharmaceuticals
Event
Event 88322
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0729-2021

Official wording

Reason: cGMP deviations: Discolored acetaminophen

Code information: Lot #: S210240, Exp. 03/2023

Distribution pattern: USA Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations