Drug product
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
D-0634-2026
Product summary
- Event
- Event 99137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 84 tubes
- Official record key
drug-enforcement:D-0634-2026
Official wording
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Code information: Lot# 0003, within expiry
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies