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Recall Observatory FDA recall evidence

Drug product

Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670

D-0092-2025

November 06, 2024

Class II

Product summary

Firm
Midlab Incorporated
Event
Event 95826
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0092-2025

Official wording

Reason: cGMP Deviations: Out of specification results for micro in hand soap products.

Code information: Lot 0711241

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations
  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification