LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only,...
FDA Recall #D-0498-2025 — Class II — June 2, 2025
Product Description
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.
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
29,700 vials
Distribution
Nationwide in the US
Code Information
Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated