Drug product
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
D-0501-2025
Product summary
- Event
- Event 96996
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,725 vials
- Official record key
drug-enforcement:D-0501-2025
Official wording
Reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Code information: Lot: 2502009, Exp. 3/2/2026
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility