KETAmine Injection Recall Due to Sterility Manufacturing Concerns
Tailstorm Health INC is recalling KETAmine Hydrochloride Injection due to sterility assurance concerns identified during FDA inspection. The recall affects 14,725 vials distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile injectable pharmaceutical product with manufacturing process concerns. No illnesses or injuries have been reported in the source material. Per the severity rubric, recalls with theoretical sterility risks and no reported harm are classified as High (3).
Plain-English summary
Tailstorm Health INC has initiated a nationwide recall of KETAmine Hydrochloride Injection, USP 500mg/5mL, supplied in 5mL sterile multi-dose vials. Lot 2502009, with an expiration date of March 2, 2026, is affected. Approximately 14,725 vials have been distributed nationwide.
The recall was prompted by FDA inspection findings that identified concerns with the sterile manufacturing process, resulting in a lack of assurance of sterility. This presents a potential risk to patients receiving the medication.
Healthcare providers should immediately remove affected vials from use and contact Tailstorm Health INC for further guidance. Patients who may have received injections from this lot should consult their healthcare provider.
The recalled product
- 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.
- Manufacturer
- Tailstorm Health INC
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 2502009
- Exp. 3/2/2026
Distribution
Distributed nationwide across the United States.
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