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Recall Observatory FDA recall evidence

Drug product

ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7

D-0063-2025

October 24, 2024

Class II

Product summary

Firm
Unexo Life Sciences Private Limited
Event
Event 95595
Status
Terminated
Classification
Class II
Quantity
4,968,000 patches
Official record key
drug-enforcement:D-0063-2025

Official wording

Reason: cGMP Deviations

Code information: UPC 8 89476 41318 3, UPC 8 89476 41336 7

Distribution pattern: Nationwide in the US

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations