FDA-Drug2025-11-26Class IIPROCESSING DEFECT
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.
Hazard
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Who it affects
All ages
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
1,480 packets
Manufactured in
7777 W Side Ave, North Bergen, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0162-2026Don't want to check this manually?
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