Tailstorm Health INC 2025-07-09 Health serious FDA
Health · FDA · Recall #FDA-D-0501-2025
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL… Recall
Issued July 9, 2025 · Tailstorm Health INC
In July 2025, Tailstorm Health INC recalled the KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
What you should do
- 1 Stop using KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Tailstorm Health INC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Tailstorm Health INC
- Category
- Health
- Recall date
- July 9, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the US
- Recall number
- FDA-D-0501-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Tailstorm Health INC has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.