Drug Enforcement D-0489-2025

Discoloration; discolored solution from cracked vials

Status

Ongoing

Classification

Class II

Report Date

July 2, 2025

Termination Date

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Product Information

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
Product quantity
98,410 vials
Reason for recall
Discoloration; discolored solution from cracked vials
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Pfizer Inc.
Address
235 East 42nd Street

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0489-2025
Event ID
96947
Recall initiation date
May 28, 2025
Center classification date
June 23, 2025
Code info
Lot KA5023, exp 02/28/2026
More code info
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