FDA-Drug2025-11-26Class IIPROCESSING DEFECT

KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

OTHERNationwide distributiondrug
Hazard

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Who it affects
All ages
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
15,267 cartridges
Manufactured in
7777 W Side Ave, North Bergen, NJ, United States
Products
KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0168-2026

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