FDAHealthJune 2, 2025
Tailstorm Health INC — 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
⚠️ Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 2, 2025
Nationwide in the US
What's affected?
- Product
- 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.
- Brand
- Tailstorm Health INC
- Lot code
- 2502008
Additional details
Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 23,200 vials.
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