Drug product
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.
D-1433-201
Product summary
- Firm
- Hospira Inc.
- Event
- Event 68751
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47,400 vials
- Official record key
drug-enforcement:D-1433-201
Official wording
Reason: Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Code information: Lot #: 39474DK, Expiry: 03/01/2016.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility