Tailstorm Health INC recalls KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, R
Recalled July 9, 2025 · FDA recall D-0500-2025 · Tailstorm Health
Hazard
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. · FDA Class II
Units
23,200 vials
Sold at
Nationwide in the US
Description
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
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.
Manufacturer(s)
Tailstorm Health INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →