FDA-Drug2025-11-26Class IIPROCESSING DEFECT
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), 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.
Intended for
All ages
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
7,736 tubes
Manufactured in
7777 W Side Ave, North Bergen, NJ, United States
Products
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2026Want us to check the next one for you?
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