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, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Onl…
- Recall number
- D-0501-2025
- 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, 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.
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