FDA-Drug2025-07-09Class II
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.
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
23,200 vials
Manufactured in
24416 N 19th Ave Ste 200, Phoenix, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0500-2025Don't want to check this manually?
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