RecallDepth
Class II Terminated

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

Company
Pfizer Inc.
Recall Initiated
July 20, 2020
Posted
August 12, 2020
Recall Number
D-1446-2020
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
19,144 vials
Firm Location
New York, NY, United States

Reason for Recall

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

Distribution

United States including Puerto Rico

Lot / Code Info

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

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