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 61924-0
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- DermaRite Industries, LLC
- 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.
- Reason / hazard
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA
- Recall initiated
- 2025-08-27
- Code info
- All lots on or before expiry date 08/2027
- Product quantity
- 7,736 tubes
- Voluntary mandated
- Voluntary: Firm initiated
- City
- North Bergen
- State
- NJ
- Country
- United States
- Event id
- 97625
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