Regadenoson Injection, Solution
FDA Recall NDC 36000-364
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Regadenoson (NDC 36000-364). A significant event, classified as Class II, was initiated on Oct 30, 2024 by Baxter Healthcare Corporation. The reported reason for this action was: "Labeling: Missing Label"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Labeling: Missing Label
Oct 30, 2024
Nov 13, 2024
60,594 units
Recall Profile & Regulatory Data
Event ID
95664
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
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
Batch or Lot Expiration Information
Lot# : 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
Affected Packages Involved in this Recall
36000-364-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
