FDA Drugs recall ·
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%… recall
- Recall number
- D-0072-2025
- Date
- (initiated October 24, 2024)
- Company / brand
- Unexo Life Sciences Private Limited
B16, Sector 4, Bawana Industrial Area, New Delhi, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 28,864 patches
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
cGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UPC 8 59424 00433 6
Distribution
Nationwide in the US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0072-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.