FDA-Drug2025-09-10Class I

KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (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

DermaRite Industries, LLC
Hazard

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

Sold states
Nationwide within the USA
Affected count
6,973 cartridges
Manufactured in
7777 W Side Ave, N/A, North Bergen, NJ, United States
Products
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (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-0612-2025

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