Warning
DermaRite Industries Recalls DermaKleen
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0163-2026Drug / Pharmaceutical
DermaRite Industries Recalls DermaKleen
DermaRite Industries, LLC · Class II — Moderate Risk
Product Description
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.
Reason for Recall
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database