Recalls / Class II
Class IID-0072-2025
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
- Brand name
- Parche Leon
- Generic name
- Capsaicin, Camphor, Menthol
- Active ingredients
- Camphor (synthetic), Capsaicin, Menthol, Unspecified Form
- Route
- Topical
- NDC
- 55758-039
- FDA application
- M017
- Affected lot / code info
- UPC 8 59424 00433 6
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- Unexo Life Sciences Private Limited
- Manufacturer
- Pharmadel LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- B16, Sector 4, Bawana Industrial Area, New Delhi, N/A, India
Distribution
- Quantity
- 28,864 patches
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-10-24
- FDA classified
- 2024-11-22
- Posted by FDA
- 2024-12-04
- Terminated
- 2025-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0072-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.