FDA Drugs recall ·
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch ( recall
- Recall number
- D-0065-2025
- Date
- (initiated October 24, 2024)
- Company / brand
- Unexo Life Sciences Private Limited
B16, Sector 4, Bawana Industrial Area, New Delhi, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 455,536 patches
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
cGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6
Distribution
Nationwide in the US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0065-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.