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PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per ...

FDA Recall #D-0072-2025 — Class II — October 24, 2024

Recall #D-0072-2025 Date: October 24, 2024 Classification: Class II Status: Terminated

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

Reason for Recall

cGMP Deviations

Recalling Firm

Unexo Life Sciences Private Limited — New Delhi

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

28,864 patches

Distribution

Nationwide in the US

Code Information

UPC 8 59424 00433 6

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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