D-1446-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 12, 2020
- Initiation Date
- July 20, 2020
- Termination Date
- December 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,144 vials
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Distribution Pattern
United States including Puerto Rico
Code Information
Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021