Tailstorm Health recalls 5mL Ketaamine vials due to FDA inspection concerns about sterile manufacturing. Affected lots expire 2027. No remedy specified.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Tailstorm Health is recalling 5mL Ketaamine Hydrochloride injections 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 problems with the sterile manufacturing process. This means the vials might not be sterile, which could cause infections if used for injections.
Prescribers and healthcare facilities that use these vials for medical injections. Patients receiving injections from these vials are at risk of infection.
Check for the vial label showing 'KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial'. Look for lot numbers 2502008 (expires 2/27/2027) or 2503001 (expires 3/4/2027).
Look for the product name and lot numbers on the vial label to confirm if it's affected.
An FDA inspection found concerns with the sterile manufacturing process, which could lead to infections if the product is not properly sterile.
The recall record does not specify a remedy, so contact Tailstorm Health for guidance.
Check the vial label for lot numbers 2502008 (expires 2/27/2027) or 2503001 (expires 3/4/2027).
We’ve drafted a message you can send Tailstorm Health to request your refund or repair — edit it as you like.
Subject: Recall D-0500-2025 — Tailstorm Health Tailstorm Health Hello, I own a Tailstorm Health that is covered by recall D-0500-2025 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.
