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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