Drug Enforcement D-0065-2025

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

December 4, 2024

Termination Date

September 16, 2025

Product Information

Product description
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
Product quantity
455,536 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-0065-2025
Event ID
95595
Recall initiation date
October 24, 2024
Center classification date
November 22, 2024
Code info
a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6
More code info
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