D-0489-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 2, 2025
- Initiation Date
- May 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,410 vials
Product Description
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62
Reason for Recall
Discoloration; discolored solution from cracked vials
Distribution Pattern
Nationwide in the USA
Code Information
Lot KA5023, exp 02/28/2026