LIDOcaine HCL Sterile Injection recalled over sterility concerns

Recall date

June 2, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Tailstorm Health INC recalls LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Bloc…

Recall number

D-0502-2025

FDA classification

Class II

Brand / firm

Tailstorm Health INC

Sold / distributed

Nationwide in the US

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.