Tailstorm Health INC: Drug Recall

Recall #D-0501-2025 · 06/02/2025

Class II: Risk

Recall Details

Recall Number: D-0501-2025
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: 14,725 vials

Reason for Recall

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

Product Description

KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.

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.