Drug product
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
D-0160-2026
Product summary
- Event
- Event 97625
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,178 bottles
- Official record key
drug-enforcement:D-0160-2026
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