Drug product
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12
D-927-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72,300 vials
- Official record key
drug-enforcement:D-927-2013
Official wording
Reason: Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Code information: Lot: 23-505-EV, Exp. 11/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility