Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Ph
Summary
The FDA issued a Class II for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syri by Baxter Healthcare Corporation. Reason: Labeling: Missing Label.
Details
Source
Drug Recall
External ID
D-0039-2025
Action Date
2024-11-13
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
Quantity Affected: 60,594 units
Reason for Recall
Labeling: Missing Label
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-30
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0039-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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