# FDA recall D-0501-2025

> **Tailstorm Health INC** · Class II · drug recall initiated 2025-06-02.

## 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.

## Reason for recall

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

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0501-2025
- **Recalling firm:** Tailstorm Health INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-02
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Phoenix, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0501-2025

## Citation

> AI Analytics. FDA recall D-0501-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0501-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*