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
Reported: November 13, 2024 Initiated: October 30, 2024 #D-0039-2025
Product Description
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 for Recall
Labeling: Missing Label
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 60,594 units
- Distribution
- Nationwide within the USA
- Location
- Deerfield, IL
Frequently Asked Questions
What product 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. Recalled by Baxter Healthcare Corporation. Units affected: 60,594 units.
Why was this product recalled? ▼
Labeling: Missing Label
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 13, 2024. Severity: Moderate. Recall number: D-0039-2025.
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