Drug product
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
D-0169-2026
Product summary
- Event
- Event 97625
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,378 containers
- Official record key
drug-enforcement:D-0169-2026
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