KETAmine Hydrochloride Injection recall: Sterility Concern
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…
Why was KETAmine Hydrochloride Injection recalled?
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
- 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…
- Recalling firm
- Tailstorm Health INC
- Quantity
- 23,200 vials
- Distribution
- Nationwide in the US
- Recall date
- July 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)