Parche Leon Patch
FDA Recall NDC 55758-039
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Parche Leon (NDC 55758-039). A significant event, classified as Class II, was initiated on Oct 24, 2024 by Pharmadel Llc. The reported reason for this action was: "cGMP Deviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP Deviations
Oct 24, 2024
Dec 04, 2024
28,864 patches
Recall Profile & Regulatory Data
Event ID
95595
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Unexo Life Sciences Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Sep 16, 2025
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
Batch or Lot Expiration Information
Lot# UPC 8 59424 00433 6
Affected Packages Involved in this Recall
55758-039-01Product
55758-039-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
