FDAFDA · Food and drugs·Recall number D-0039-2025
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
Published November 13, 2024 · Recall initiated: October 30, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Missing Label
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- REGADENOSON
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Nationwide within the USA
- UPC
- 0336000364010
- Lot
- Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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