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Recall Observatory FDA recall evidence

Drug product

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

D-0075-2025

November 01, 2024

Class II

Product summary

Firm
JR Watkins
Event
Event 95715
Status
Terminated
Classification
Class II
Quantity
7,138 patches
Official record key
drug-enforcement:D-0075-2025

Official wording

Reason: cGMP Deviations

Code information: Lot # JC101, JC102 and JC103, exp. date Oct 31, 2025

Distribution pattern: Nationwide in the US

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations