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Recall Observatory FDA recall evidence

Drug product

THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031

D-0065-2025

October 24, 2024

Class II

Product summary

Firm
Unexo Life Sciences Private Limited
Event
Event 95595
Status
Terminated
Classification
Class II
Quantity
455,536 patches
Official record key
drug-enforcement:D-0065-2025

Official wording

Reason: cGMP Deviations

Code information: a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6

Distribution pattern: Nationwide in the US

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations