FDA Drug recall D-0500-2025
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…
- FDA Drug
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of 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… by Tailstorm Health, citing lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0500-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-02 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Tailstorm Health |
| Distribution | US |
Product
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.
Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Identifiers
| code_info | Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0500-2025%22
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