Drug 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.
D-0500-2025
Product summary
- Event
- Event 96996
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23,200 vials
- Official record key
drug-enforcement:D-0500-2025
Official wording
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Code information: Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility