D-0039-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2024
- Initiation Date
- October 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60,594 units
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
Distribution Pattern
Nationwide within the USA
Code Information
Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025