Recalls / Class II
Class IID-0039-2025
Product
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
- Brand name
- Regadenoson
- Generic name
- Regadenoson
- Active ingredient
- Regadenoson
- Route
- Intravenous
- NDC
- 36000-364
- FDA application
- ANDA217455
- Affected lot / code info
- Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
Why it was recalled
Labeling: Missing Label
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 60,594 units
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2024-10-30
- FDA classified
- 2024-11-06
- Posted by FDA
- 2024-11-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0039-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.