Class II
Ongoing
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
This recall is currently active, issued November 13, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- October 30, 2024
- Posted
- November 13, 2024
- Recall Number
- D-0039-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 60,594 units
- Firm Location
- Deerfield, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Missing Label
Distribution
Nationwide within the USA
Lot / Code Info
Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
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