Regadenoson Injection recall: Labeling Error
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…
Why was Regadenoson Injection recalled?
Labeling: Missing Label
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
- 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…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 60,594 units
- Distribution
- Nationwide within the USA
- Recall date
- November 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)