Recalls / Class II
Class IID-0500-2025
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.
- Affected lot / code info
- Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Recalling firm
- Firm
- Tailstorm Health INC
- Type
- Voluntary: Firm initiated
- Address
- 24416 N 19th Ave Ste 200, Phoenix, Arizona 85085-1400
Distribution
- Quantity
- 23,200 vials
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-06-02
- FDA classified
- 2025-06-30
- Posted by FDA
- 2025-07-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0500-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.