Class II
Ongoing
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.
This recall is currently active, issued July 9, 2025. It was issued by Tailstorm Health Inc.
- Company
- Tailstorm Health Inc
- Recall Initiated
- June 2, 2025
- Posted
- July 9, 2025
- Recall Number
- D-0500-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23,200 vials
- Firm Location
- Phoenix, AZ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Distribution
Nationwide in the US
Lot / Code Info
Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
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