KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile M...
FDA Recall #D-0501-2025 — Class II — June 2, 2025
Product Description
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.
Recalling Firm
Tailstorm Health INC — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
14,725 vials
Distribution
Nationwide in the US
Code Information
Lot: 2502009, Exp. 3/2/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated