Why it was recalled
cGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
UPC 8 59424 00433 6
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0072-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 24, 2024
- FDA report date
- Dec 4, 2024
- Quantity
- 28,864 patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unexo Life Sciences Private Limited
Original FDA data
Every field from FDA enforcement report D-0072-2025, exactly as published.
Show all FDA fields
- City
- New Delhi
- Status
- Terminated
- Country
- India
- Event ID
- 95595
- Address
- B16, Sector 4, Bawana Industrial Area
- Code information
- UPC 8 59424 00433 6
- Report date
- Dec 4, 2024
- Product type
- Drugs
- Recall number
- D-0072-2025
- Classification
- Class II
- Recalling firm
- Unexo Life Sciences Private Limited
- Product quantity
- 28,864 patches
- Termination date
- Sep 16, 2025
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Oct 24, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 22, 2024