Why it was recalled
Labeling: Missing Label
Product description
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01
Lot numbers, UPCs & expiration codes
Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
Where it was sold
Nationwide within the USA
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-0039-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 30, 2024
- FDA report date
- Nov 13, 2024
- Quantity
- 60,594 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0039-2025, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 95664
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
- Postal code
- 60015-4625
- Report date
- Nov 13, 2024
- Product type
- Drugs
- Recall number
- D-0039-2025
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 60,594 units
- Reason for recall
- Labeling: Missing Label
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- Oct 30, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2024