LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Inf...
FDA Recall #D-0502-2025 — Class II — June 2, 2025
Product Description
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.
Recalling Firm
Tailstorm Health INC — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2825 vials
Distribution
Nationwide in the US
Code Information
Lot #s: 2503004, Exp. 3/23/2026; 2503005, Exp. 3/25/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.