FDA Drug Class II — Moderate

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

Hazard

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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Products

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
Brand
DermaRite Industries, LLC
UPC
All lots on or before expiry date 08/2027

Units Affected

15,465 cartridges

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