Recall: D-0039-2025

Class II - Potentially Harmful

Class IIClassification

2024-10-30Initiated

OngoingStatus

Baxter Healthcare CorporationFirm

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

Reason

Labeling: Missing Label

Distribution

Nationwide within the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.