Ketamine Injection Recalled Due to Sterility Assurance Concerns
Tailstorm Health is recalling Ketamine Hydrochloride Injection due to manufacturing process concerns that could affect product sterility. The recall involves 23,200 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 drug recall with no reported illnesses or injuries. The hazard is theoretical—potential sterility failures identified during FDA inspection. Per the rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Tailstorm Health Inc. is recalling Ketamine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL) formulation supplied in 5 mL sterile single-dose vials. The recall affects 23,200 vials with lot numbers 2502008 (expiration 2/27/2027) and 2503001 (expiration 3/4/2027), which were distributed nationwide.
A recent FDA inspection identified concerns with the sterile manufacturing process used to produce this product. These concerns create a potential risk that affected units may not be adequately sterile.
Healthcare facilities and medical professionals who have received affected lots should immediately stop using the recalled product and contact the manufacturer, Tailstorm Health Inc., for return instructions. Patients who may have received injections from affected lots should contact their healthcare provider.
The recalled product
- 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.
- Manufacturer
- Tailstorm Health INC
- Hazard
- lack-of-sterility
- 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 (4)
- Lot #s: 2502008
- Exp. 2/27/2027
- 2503001
- Exp. 3/4/2027.
Distribution
Distributed nationwide across the United States.
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