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Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Man...

FDA Recall #D-0039-2025 — Class II — October 30, 2024

Recall #D-0039-2025 Date: October 30, 2024 Classification: Class II Status: Ongoing

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

Reason for Recall

Labeling: Missing Label

Recalling Firm

Baxter Healthcare Corporation — Deerfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

60,594 units

Distribution

Nationwide within the USA

Code Information

Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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