DermaRite Industries, LLC: Drug Recall
Recall #D-0610-2025 · 07/17/2025
Class I: Dangerous
Recall Details
- Recall Number
- D-0610-2025
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- DermaRite Industries, LLC
- Status
- Ongoing
- Date Initiated
- 07/17/2025
- Location
- North Bergen, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,321 bag in boxes
Reason for Recall
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Product Description
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Distribution Pattern
Nationwide within the USA
Other Recalls by DermaRite Industries, LLC
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
- Class II: Risk 08/27/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.