FDA-Drug2025-07-09Class II

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.

Tailstorm Health INC
Hazard

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

Sold states
Nationwide in the US
Affected count
29,700 vials
Manufactured in
24416 N 19th Ave Ste 200, Phoenix, AZ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0498-2025

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