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
D-0489-2025
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 96947
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 98,410 vials
- Official record key
drug-enforcement:D-0489-2025
Official wording
Reason: Discoloration; discolored solution from cracked vials
Code information: Lot KA5023, exp 02/28/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Discoloration; discolored solution from cracked vials