Drug Enforcement D-0070-2025

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

December 4, 2024

Termination Date

September 16, 2025

Product Information

Product description
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5
Product quantity
10,368 patches
Reason for recall
cGMP Deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the US

Location & Firm

Recalling firm
Unexo Life Sciences Private Limited
Address
B16, Sector 4, Bawana Industrial Area

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0070-2025
Event ID
95595
Recall initiation date
October 24, 2024
Center classification date
November 22, 2024
Code info
UPC 8 56294 00878 5
More code info
—