D-0162-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 26, 2025
- Initiation Date
- August 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,480 packets
Product Description
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Reason for Recall
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Distribution Pattern
Nationwide in the USA
Code Information
All lots on or before expiry date 08/2027