Drug product
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
D-502-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65225
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44,748 bags
- Official record key
drug-enforcement:D-502-2013
Official wording
Reason: Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Code information: Lot 11-309-KL
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility