Recalls / Class II

Class IID-0501-2025

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.

Affected lot / code info

Lot: 2502009, Exp. 3/2/2026

Why it was recalled

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Recalling firm

Firm

Tailstorm Health INC

Type

Voluntary: Firm initiated

Address

24416 N 19th Ave Ste 200, Phoenix, Arizona 85085-1400

Distribution

Quantity

14,725 vials

Distribution pattern

Nationwide in the US

Timeline

Recall initiated

2025-06-02

FDA classified

2025-06-30

Posted by FDA

2025-07-09

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0501-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.