Recalls / Class I
Class ID-0610-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Affected lot / 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.
Why it was recalled
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Recalling firm
- Firm
- DermaRite Industries, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7777 W Side Ave, N/A, North Bergen, New Jersey 07047-6436
Distribution
- Quantity
- 11,321 bag in boxes
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2025-07-17
- FDA classified
- 2025-09-02
- Posted by FDA
- 2025-09-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0610-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.