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FDARecalled Jul 9, 2025 · #D-0498-2025

LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use ...

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Classification: Class II Distribution: Nationwide in the US

Product details

Product
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0.
Type
Drugs
Manufacturer
Tailstorm Health INC
Model numbers
UPCs