Reported Jul 2, 2025 · Ongoing
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only,…
Pfizer Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfizer Inc. · 235 East 42nd Street · New York, NY · 10017-5703
Is this the product you have?
- 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 Carton0409-2344-02
- NDC Vial0409-2344-62
- Lot codes and dates
Lot KA5023exp 02/28/2026
- Amount recalled
- 98,410 vials
Where it was sold
- Nationwide
Why it was recalled
Discoloration; discolored solution from cracked vials
This product could cause temporary or reversible health problems — stop using it.
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