Regadenoson Injection 0.4 mg/5mL 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…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Regadenoson Injection 0.4 mg/5mL recalled?
Labeling: Missing Label
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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
Which lot codes, UPCs or models are affected?
Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
- Agency record number
- D-0039-2025
- 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 started
- October 30, 2024
- Report date
- November 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)