Recalls / Class II
Class IID-0160-2026
Product
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
- Affected lot / code info
- All lots on or before expiry date 08/2027.
Why it was recalled
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recalling firm
- Firm
- DermaRite Industries, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 7777 W Side Ave, North Bergen, New Jersey 07047-6436
Distribution
- Quantity
- 3,178 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-08-27
- FDA classified
- 2025-11-20
- Posted by FDA
- 2025-11-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0160-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.