Drug 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.
D-0162-2026
Product summary
- Event
- Event 97625
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,480 packets
- Official record key
drug-enforcement:D-0162-2026
Official wording
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Code information: All lots on or before expiry date 08/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviation