FDAHealthOctober 30, 2024
Baxter Healthcare Corporation — 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 474
⚠️ Labeling: Missing Label
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 30, 2024
Nationwide within the USA
What's affected?
- 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
- Brand
- REGADENOSON
- UPC
- 0336000364010
- Lot code
- 945169
Additional details
Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 60,594 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.