D-0039-2025Class II

Baxter Healthcare Corporation

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-11-13

Distribution

Nationwide within the USA

Firm state

Product quantity

60,594 units

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

Labeling: Missing Label

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.