Drug Enforcement D-0039-2025

Labeling: Missing Label

Status

Ongoing

Classification

Class II

Report Date

November 13, 2024

Termination Date

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Product Information

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
Product quantity
60,594 units
Reason for recall
Labeling: Missing Label
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the USA

Location & Firm

Recalling firm
Baxter Healthcare Corporation
Address
1 Baxter Pkwy, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0039-2025
Event ID
95664
Recall initiation date
October 30, 2024
Center classification date
November 6, 2024
Code info
Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
More code info
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