Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

KETAmine Hydrochloride Injection Recalled by Tailstorm Health INC Due to Lack of Assurance of Sterility: A recent FDA...

Date: June 2, 2025
Company: Tailstorm Health INC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tailstorm Health INC directly.

Affected Products

KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.

Quantity: 23,200 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Tailstorm Health INC

Tailstorm Health INC has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report