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.
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