Tailstorm Health recalls Ketaamine hydrochloride injection vials due to FDA inspection concerns about sterile manufacturing. This affects specific lot numbers and compounded drug products.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Tailstorm Health is recalling Ketaamine hydrochloride injection vials because an FDA inspection found issues with the sterile manufacturing process. This could lead to infections if the product is not properly sterile.
The FDA inspection identified concerns about the sterile manufacturing process. This means the product might not be sterile, which could cause infections if used improperly.
Patients prescribed this medication by healthcare providers who received the specific lot number (2502009) from Medivant Healthcare. Those using the product for medical procedures are most at risk.
Check for the lot number 2502009 on the vial label. The product is a 5mL sterile multi-dose vial compounded by Medivant Healthcare in Chandler, AZ.
Look for the lot number 2502009 on the vial label to confirm if it is affected.
The FDA has raised concerns about the sterile manufacturing process, so the product may not be sterile and could cause infections. Do not use until the recall is addressed.
Check for the lot number 2502009 on the vial label. The product is a 5mL sterile multi-dose vial compounded by Medivant Healthcare in Chandler, AZ.
Check the vial label for the lot number 2502009. If it matches, contact your healthcare provider for guidance on next steps.
We’ve drafted a message you can send Tailstorm Health to request your refund or repair — edit it as you like.
Subject: Recall D-0501-2025 — Tailstorm Health Tailstorm Health Hello, I own a Tailstorm Health that is covered by recall D-0501-2025 from Tailstorm Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
