Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by
Summary
The FDA issued a Class III for Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, by Asclemed USA Inc.. Reason: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan.
Details
Source
Drug Recall
External ID
D-0713-2026
Action Date
2026-07-29
Status
Ongoing
Category
drug
Product Description
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01.
Lot/Code Info: Lot: 070126X1, Exp. 12/31/2027.
Quantity Affected: 18 kits
Reason for Recall
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Distribution
Within U.S. - Tennessee
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-15
Company
Torrance, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 43 drug recalls issued in the same week, part of 88 drug-related FDA actions this month.
Asclemed USA Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Asclemed USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Asclemed USA Inc. have FDA actions?
Asclemed USA Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0713-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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