FDAFDA · Food and drugs·Recall number D-0500-2025
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.
Published July 9, 2025 · Recall initiated: June 2, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Tailstorm Health INC
- Distributor
- Nationwide in the US
- Lot
- Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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