FDA-Drug2025-07-02Class II
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
Pfizer Inc.
Hazard
Discoloration; discolored solution from cracked vials
Sold states
Nationwide in the USA
Affected count
98,410 vials
Manufactured in
235 East 42nd Street, New York, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2025Don't want to check this manually?
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