Drug product
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
D-309-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64720
- Status
- Terminated
- Classification
- Class II
- Quantity
- 172,350 vials
- Official record key
drug-enforcement:D-309-2013
Official wording
Reason: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Code information: Lot 17-100-EV and 17-399-EV
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility