FDA recall D-0423-2025
KENIL HEALTHCARE PRIVATE LIMITED · Class II · 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.
Reason for recall
CGMP Deviations
Distribution
DE and NC
Key facts
- Status
- Terminated
- Initiation date
- 2025-04-24
- Report date
- 2025-05-28
- Termination date
- 2026-02-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Ta. Kadi, District Mehsana, N/A, India
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0423-2025