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Recall Observatory FDA recall evidence

Drug product

boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015

D-0088-2025

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-0088-2025

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