Drug product
Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.
D-023-2014
Product summary
- Firm
- Hospira, Inc.
- Event
- Event 66435
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,700 vials
- Official record key
drug-enforcement:D-023-2014
Official wording
Reason: Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
Code information: Lot #17368EV Exp 08/13
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility