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-501-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65315
- Status
- Terminated
- Classification
- Class II
- Quantity
- 95,700 vials
- Official record key
drug-enforcement:D-501-2013
Official wording
Reason: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Code information: 17-099-EV Exp 05/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility