Recalls / Class II
Class IID-0065-2025
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
- Brand name
- Theracare Maximum Strength Pain Relief Patch
- Generic name
- Lidocaine
- Active ingredient
- Lidocaine
- Route
- Topical
- NDC
- 71101-001
- FDA application
- M017
- Affected lot / code info
- a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- Unexo Life Sciences Private Limited
- Manufacturer
- Veridian Healthcare
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- B16, Sector 4, Bawana Industrial Area, New Delhi, N/A, India
Distribution
- Quantity
- 455,536 patches
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-10-24
- FDA classified
- 2024-11-22
- Posted by FDA
- 2024-12-04
- Terminated
- 2025-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0065-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.