Drug product
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
D-1446-2020
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 86074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,144 vials
- Official record key
drug-enforcement:D-1446-2020
Official wording
Reason: Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Code information: Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021
Distribution pattern: United States including Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility