Status
Ongoing
Drug Enforcement D-0610-2025
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Classification
Class I
Report Date
September 10, 2025
Termination Date
—
Product Information
- 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.
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the USA
Location & Firm
- Recalling firm
- DermaRite Industries, LLC
- Address
-
7777 W Side Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0610-2025
- Event ID
- 97277
- Recall initiation date
- July 17, 2025
- Center classification date
- September 2, 2025
- Code info
- Lot # and Expiration Date: a) 30550A, Exp. Date 7/2025; 30670A, 30682A, Exp. Date 8/2025; 40025A, Exp. Date 1/2026; 40375A, Exp. Date 4/2026; 40427A, 40436A, Exp. Date 5/2026; 50068A, Exp. Date 1/2027. b)30586A, 30586B, 30626A, Exp. Date 7/2025; 30628A, 30657A, Exp. Date 8/2025; 30741A, Exp. Date 7/2025; 30871A, Exp. Date 10/2025; 40002A, Exp. Date 12/2025; 40012A, Exp. Date 1/2026; 40301A, Exp. Date 3/2026; 40789 A, Exp. Date 9/2026; 50068B, Exp. Date 1/2027; 50144A, 50149A, Exp. Date 2/2027.
- More code info
- —