Drug Enforcement D-0063-2025

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

December 4, 2024

Termination Date

September 16, 2025

Product Information

Product description
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
Product quantity
4,968,000 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-0063-2025
Event ID
95595
Recall initiation date
October 24, 2024
Center classification date
November 22, 2024
Code info
UPC 8 89476 41318 3, UPC 8 89476 41336 7
More code info
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