PeriGiene Antiseptic Recalled Due to Manufacturing Facility Contamination
DermaRite Industries recalls PeriGiene Health Care Antiseptic nationwide because other products at the manufacturing facility were found contaminated. The recall affects 16,006 units distributed in the USA.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a healthcare antiseptic product with confirmed CGMP deviation and contamination issues at the manufacturing facility. Although no illnesses have been reported, the product poses a risk of harm due to manufacturing defects.
Plain-English summary
DermaRite Industries, LLC is recalling PeriGiene Health Care Antiseptic (Chloroxylenol 0.5%) in 222mL bottles nationwide. The recall involves 16,006 units distributed across the United States. The affected product is identified by NDC 61924-198-08.
The recall was initiated 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 be contaminated.
All lots of the product with expiration dates on or before August 2027 are included in the recall. The product was distributed nationwide.
Consumers who have purchased this product should discontinue use. For questions about the recall, contact DermaRite Industries, LLC, located at 7777 West Side Avenue, North Bergen, NJ 07047.
The recalled product
- Product
- 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
- Manufacturer
- DermaRite Industries, LLC
- Hazard
- cgmp-deviation
- manufacturing-contamination
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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