FDA-Drug2025-07-09Class II
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.
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
975 vials
Manufactured in
24416 N 19th Ave Ste 200, Phoenix, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0499-2025Don't want to check this manually?
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