Class IIReported 2025-07-09

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 Number

D-0500-2025

Classification

Class II

Status

Ongoing