Reported Nov 13, 2024 · Ongoing
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter…
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only
- Manufactured byBaxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403
- Manufactured forBaxter Healthcare Corporation, Deerfield, IL 60015
- NDC36000-364-01
- Lot codes and dates
Lot #: 945169Exp. Date 9/25/2025945170Exp. Date 10/24/2025
- Amount recalled
- 60,594 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Missing Label
This product could cause temporary or reversible health problems — stop using it.
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