Reported Jul 9, 2025 · Ongoing
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx…
Tailstorm Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tailstorm Health INC · 24416 N 19th Ave Ste 200 · Phoenix, AZ · 85085-1400
Is this the product you have?
- 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 Healthcare158 S. KyreneRd. ChandlerAZ 85226NDC 81483-0007-2
- Lot codes and dates
- Lot
2502009Exp. 3/2/2026
- Lot
- Amount recalled
- 14,725 vials
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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