DermaKleen Antiseptic Soap Recalled Due to Manufacturing Defect Risk
DermaKleen Health Care Antiseptic Lotion Soap is being recalled nationwide due to a Current Good Manufacturing Practice (CGMP) deviation at the manufacturer. The facility previously produced contaminated lots of other products.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a CGMP deviation at a manufacturing facility. No illnesses or injuries have been reported. The recall is precautionary based on contamination found in other products at the same facility.
Plain-English summary
DermaRite Industries, LLC is recalling DermaKleen Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%) distributed nationwide. The recall involves three package sizes: 222 mL tubes (NDC 61924-092-08), 800 mL bags (NDC 61924-092-27), and 1000 mL bags (NDC 61924-092-34). All lots with expiration dates on or before August 2027 are affected.
The recall is due to a Current Good Manufacturing Practice (CGMP) deviation at the manufacturing facility. Other products and lots manufactured at the same facility have been found to contain contamination. This recall is precautionary to protect public health.
Consumers who have purchased this product should stop use immediately. Contact your healthcare provider or DermaRite Industries, LLC at 7777 West Side Avenue, North Bergen, NJ 07047 for instructions on returning or safely disposing of the product.
The recalled product
- Product
- 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,
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- facility-contamination
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots on or before expiry date 08/2027
Distribution
Distributed nationwide across the United States.
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