Recalls / Class II

Class IID-0499-2025

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.

Affected lot / code info

Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026

Why it was recalled

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

Recalling firm

Firm

Tailstorm Health INC

Type

Voluntary: Firm initiated

Address

24416 N 19th Ave Ste 200, Phoenix, Arizona 85085-1400

Distribution

Quantity

975 vials

Distribution pattern

Nationwide in the US

Timeline

Recall initiated

2025-06-02

FDA classified

2025-06-30

Posted by FDA

2025-07-09

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0499-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.