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DermaRite Industries, LLC: San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61

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
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34
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
15,465 cartridges
Voluntary mandated
Voluntary: Firm initiated
City
North Bergen
State
NJ
Country
United States
Event id
97625
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