THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 p
Summary
The FDA issued a Class II for THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101 by Unexo Life Sciences Private Limited. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0065-2025
Action Date
2024-12-04
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6
Quantity Affected: 455,536 patches
Reason for Recall
cGMP Deviations
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-24
Company
New Delhi
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Unexo Life Sciences Private Limited has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Unexo Life Sciences Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Unexo Life Sciences Private Limited have FDA actions?
Unexo Life Sciences Private Limited has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0065-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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