FDA recall D-0499-2025

Tailstorm Health INC · Class II · drug

Product

BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.

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-0499-2025