Tailstorm Health INC: Drug Recall

Recall #D-0499-2025 · 06/02/2025

Class II: Risk

Recall Details

Recall Number: D-0499-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Tailstorm Health INC
Status: Ongoing
Date Initiated: 06/02/2025
Location: Phoenix, AZ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 975 vials

Reason for Recall

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

Product Description

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.

Distribution Pattern

Nationwide in the US

Other Recalls by Tailstorm Health INC

Class II: Risk 06/02/2025

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II: Risk 06/02/2025

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II: Risk 06/02/2025

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II: Risk 06/02/2025

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II: Risk 06/02/2025

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

View all recalls by Tailstorm Health INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.