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

Recall Number: D-1446-2020

Firm: Pfizer Inc.

Classification: Class II

Status: Terminated

Report Date: 20200812

Initiation Date: 20200720

Termination Date: 20221208

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

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