FDA-Drug2025-07-09Class II
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.
Tailstorm Health INC
Hazard
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Sold states
Nationwide in the US
Affected count
14,725 vials
Manufactured in
24416 N 19th Ave Ste 200, Phoenix, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0501-2025Don't want to check this manually?
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