FDA-Drug2025-07-09Class II
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
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
4875 vials
Manufactured in
24416 N 19th Ave Ste 200, Phoenix, AZ, United States
Products
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0503-2025Don't want to check this manually?
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