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
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Classification
Class II
Status
Ongoing
Lot
Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Tailstorm Health INC — Class II Recall | MedicineWatch US