Drug product
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
D-0172-2026
Product summary
- Event
- Event 97625
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16,006 units
- Official record key
drug-enforcement:D-0172-2026
Official wording
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Code information: All lots on or before expiry date 08/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviation