FDA-Drug2024-11-13Class II
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
Baxter Healthcare Corporation
Hazard
Labeling: Missing Label
Sold states
Nationwide within the USA
Affected count
60,594 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0039-2025Don't want to check this manually?
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