Product: 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 initiated: 20250602
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated