Drug product
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
D-308-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64720
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,100 vials
- Official record key
drug-enforcement:D-308-2013
Official wording
Reason: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Code information: Lot 15-065-DK, Exp 1SEP2013
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility