FDA Drugs recall ·
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL)… recall
- Recall number
- D-0039-2025
- Date
- (initiated October 30, 2024)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 60,594 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Labeling: Missing Label
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
Distribution
Nationwide within the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0039-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.