Drug recall D-1446-2020

Class II Terminated reported Aug 12, 2020

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

Reason for recall

Lack of Assurance of Sterility; potential loose metal overseal crimp defects.

Lots and codes

Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021

Recall details

Recalling firm
Pfizer Inc., New York, NY
Quantity
19,144 vials
Distribution
United States including Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
July 20, 2020
Terminated
December 8, 2022

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