DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fl...
FDA Recall #D-0489-2025 — Class II — May 28, 2025
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
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
98,410 vials
Distribution
Nationwide in the USA
Code Information
Lot KA5023, exp 02/28/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated