Drug product
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
D-0039-2025
Product summary
- Event
- Event 95664
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60,594 units
- Official record key
drug-enforcement:D-0039-2025
Official wording
Reason: Labeling: Missing Label
Code information: Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Labeling or packaging
Labeling: Missing