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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.)

DrugsSource: FDA (drug) · Date: 2025-11-26

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
DermaRite Industries, LLC
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.
Reason / hazard
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2025-08-27
Code info
All lots on or before expiry date 08/2027
Product quantity
1,480 packets
Voluntary mandated
Voluntary: Firm initiated
City
North Bergen
State
NJ
Country
United States
Event id
97625
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