KleenFoam Antimicrobial Foam Soap Recalled Due to Manufacturing Control Deviation
DermaRite Industries is recalling KleenFoam Antimicrobial Foam Soap cartridges due to manufacturing control (CGMP) deviations at the facility where contamination was found in other product lots. The product is distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a drug product due to CGMP deviation and facility contamination discovered in other product lots. While no illnesses or injuries are reported in the source text, the manufacturing control failure constitutes a risk-of-harm product.
Plain-English summary
DermaRite Industries, LLC is recalling 15,267 cartridges of KleenFoam Antimicrobial Foam Soap (Chloroxylenol 0.5%, 34 FL OZ/1000 mL per cartridge) distributed nationwide in the United States. The recall affects all lots with expiration dates on or before August 2027.
The recall was initiated due to a current good manufacturing practice (CGMP) deviation at the manufacturing facility. Other products and lots produced at the same facility were found to be contaminated, which prompted this recall.
Consumers who have purchased this product should stop using it and dispose of it safely or contact DermaRite Industries for further instructions. Patients in healthcare settings using this product should consult with their healthcare providers regarding alternative products.
The recalled product
- Product
- 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
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Antimicrobial Soap
- Hazard
- contamination
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots on or before expiry date 08/2027
Distribution
Distributed nationwide across the United States.
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