Drug Enforcement D-0075-2025

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

December 4, 2024

Termination Date

September 16, 2025

Product Information

Product description
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
Product quantity
7,138 patches
Reason for recall
cGMP Deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the US

Location & Firm

Recalling firm
JR Watkins
Address
400 Mill St Unit #D5

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0075-2025
Event ID
95715
Recall initiation date
November 1, 2024
Center classification date
November 27, 2024
Code info
Lot # JC101, JC102 and JC103, exp. date Oct 31, 2025
More code info
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