FDAHealthAugust 27, 2025
DermaRite Industries, LLC — DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) p
⚠️ CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 27, 2025
Nationwide in the USA
What's affected?
- Product
- DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Lot code
- on
Additional details
All lots on or before expiry date 08/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7,736 tubes.
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