FDA recall D-0065-2025

Unexo Life Sciences Private Limited · Class II · 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

Reason for recall

cGMP Deviations

Distribution

Nationwide in the US

Key facts

Status: Terminated
Initiation date: 2024-10-24
Report date: 2024-12-04
Termination date: 2025-09-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: New Delhi, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0065-2025