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.
Reason for recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Recall initiated: 20250602
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated