FDA recall D-0489-2025

Pfizer Inc. · Class II · drug

Product

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

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-05-28
Report date: 2025-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2025