Drug product
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
D-0175-2026
Product summary
- Event
- Event 97625
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 57,041 units
- Official record key
drug-enforcement:D-0175-2026
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