D-0039-2025 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Drugs
Report Date
November 13, 2024
Initiation Date
October 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60,594 units

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

Distribution Pattern

Nationwide within the USA

Code Information

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