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FDARecalled Jul 9, 2025 · #D-0501-2025

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...

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Classification: Class II Distribution: Nationwide in the US

Product details

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.
Type
Drugs
Manufacturer
Tailstorm Health INC
Model numbers
2502009
UPCs