Drug product
CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
D-0423-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,788 Tubes
- Official record key
drug-enforcement:D-0423-2025
Official wording
Reason: CGMP Deviations
Code information: Lot SP23A, Exp Date: 03/31/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations