Drug & medication recalls Moderate risk

PARCHE LEON PAIN RELIEVING HOT PATCH recalled over manufacturing violations

Recall date
October 24, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Unexo Life Sciences Private Limited recalls PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: P…
Recall number
D-0072-2025
FDA classification
Class II
Brand / firm
Unexo Life Sciences Private Limited
Sold / distributed
Nationwide in the US

Why it was recalled

cGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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