FDA recall D-0072-2025

Unexo Life Sciences Private Limited · Class II · 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

Reason for recall

cGMP Deviations

Distribution

Nationwide in the US

Key facts

Status: Terminated
Initiation date: 2024-10-24
Report date: 2024-12-04
Termination date: 2025-09-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: New Delhi, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0072-2025