Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0500-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 2, 2025
- FDA report date
- Jul 9, 2025
- Quantity
- 23,200 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tailstorm Health INC
Original FDA data
Every field from FDA enforcement report D-0500-2025, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96996
- Address
- 24416 N 19th Ave Ste 200
- Code information
- Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
- Postal code
- 85085-1400
- Report date
- Jul 9, 2025
- Product type
- Drugs
- Recall number
- D-0500-2025
- Classification
- Class II
- Recalling firm
- Tailstorm Health INC
- Product quantity
- 23,200 vials
- Reason for recall
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jun 2, 2025
- Center classification date
- Jun 30, 2025