FDAHealthAugust 27, 2025
DermaRite Industries, LLC — 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) Der
⚠️ 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
- 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.
- 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: 1,480 packets.
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