FDA Drug Class II — Moderate

PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

Hazard

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

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Products

PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Brand
DermaRite Industries, LLC
UPC
All lots on or before expiry date 08/2027

Units Affected

16,006 units

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