Compounded ketamine injection recalled over lack of sterility assurance concerns
Ketamine Hydrochloride Injection compounded by Medivant Healthcare is being recalled for lack of assurance of sterility after an FDA inspection raised concerns about the sterile manufacturing process.
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: Risk-of-harm product: an injectable with no assurance of sterility, where no infection or injury is reported in the source.
Plain-English summary
Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), for intramuscular use or slow intravenous use, 5 mL sterile single-dose vial, prescription only, for office use only, compounded by Medivant Healthcare of Chandler, Arizona, NDC 81483-0006-0, is being recalled. The action covers 23,200 vials.
The stated reason is a lack of assurance of sterility: a recent FDA inspection revealed concerns with the sterile manufacturing process. The FDA classified the action as Class II.
Affected lots are 2502008, expiring 2/27/2027, and 2503001, expiring 3/4/2027. Distribution was nationwide in the US. The vials are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the NDC and lot numbers above, stop using it, and follow the instructions issued by the compounder.
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
- Category
- Drug — Compounded injectable
- Affected units
- 23,200
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.
Part of a larger recall action
This product is one of 6 recalled by Tailstorm Health INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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