Class IIReported 2025-07-09

LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.

Reason for Recall

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Recall Number

D-0502-2025

Classification

Class II

Status

Ongoing