Tailstorm Health INC recalls KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only
Recalled July 9, 2025 · FDA recall D-0501-2025 · Tailstorm Health
Hazard
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. · FDA Class II
Units
14,725 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, 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.
Manufacturer(s)
Tailstorm Health INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →