Drug & medication recalls Moderate risk

Baxter Healthcare Corporation recalls Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter P…

Recall date
October 30, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0039-2025
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Nationwide within the USA

Why it was recalled

Labeling: Missing Label

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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