Drug product
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6
D-0072-2025
Product summary
- Event
- Event 95595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,864 patches
- Official record key
drug-enforcement:D-0072-2025
Official wording
Reason: cGMP Deviations
Code information: UPC 8 59424 00433 6
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
cGMP Deviations