Drug Enforcement D-0064-2025

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

December 4, 2024

Termination Date

September 16, 2025

Product Information

Product description
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402
Product quantity
946,080 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-0064-2025
Event ID
95595
Recall initiation date
October 24, 2024
Center classification date
November 22, 2024
Code info
a) UPC 8 89476 41251 3 b) UPC 8 89476 41306 0
More code info