Status
Ongoing
Drug Enforcement D-0500-2025
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Classification
Class II
Report Date
July 9, 2025
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 23,200 vials
- Reason for recall
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- Tailstorm Health INC
- Address
-
24416 N 19th Ave Ste 200
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0500-2025
- Event ID
- 96996
- Recall initiation date
- June 2, 2025
- Center classification date
- June 30, 2025
- Code info
- Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
- More code info
- —