Recalls / Class II

Class IID-0502-2025

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.

Affected lot / code info

Lot #s: 2503004, Exp. 3/23/2026; 2503005, Exp. 3/25/2026

Why it was recalled

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

Recalling firm

Firm

Tailstorm Health INC

Type

Voluntary: Firm initiated

Address

24416 N 19th Ave Ste 200, Phoenix, Arizona 85085-1400

Distribution

Quantity

2825 vials

Distribution pattern

Nationwide in the US

Timeline

Recall initiated

2025-06-02

FDA classified

2025-06-30

Posted by FDA

2025-07-09

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0502-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.