KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Ster...
FDA Recall #D-0500-2025 — Class II — June 2, 2025
Product Description
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.
Recalling Firm
Tailstorm Health INC — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
23,200 vials
Distribution
Nationwide in the US
Code Information
Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated