FDA recall D-0498-2025

Tailstorm Health INC · Class II · drug

Product

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.

Distribution

Nationwide in the US

Key facts

Status
Ongoing
Initiation date
2025-06-02
Report date
2025-07-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Phoenix, AZ, United States

Primary source

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