[pending] DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 8
Pending LLM rewrite. Source: FDA_DRUG D-0610-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
The recalled product
- 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.
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Drugs
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 (20)
- 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
- 30628A
- 30657A
- 30741A
- 30871A
Distribution
Distributed nationwide across the United States.
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