KETAmine Hydrochloride Injection recalled over sterility concerns

Recall date

June 2, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Tailstorm Health INC recalls KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial,…

Recall number

D-0500-2025

FDA classification

Class II

Brand / firm

Tailstorm Health INC

Sold / distributed

Nationwide in the US

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.