Recalls / Class I
Class ID-0613-2025
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
PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
- Affected lot / code info
- Lot #: 31013A, Exp. Date 11/2025; 40345A, 40355A, Exp. Date 4/2026; 40571A, 40580A, Exp. Date 6/2026; 40587A, 40591A, Exp. Date 7/2026; 40870.1, 40877.1, Exp. Date 10/2026; 41093A, Exp. Date 12/2026; 50072A, 50079A, Exp. Date 1/2027
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
- 5,703 bottles
- 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-0613-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.