FDA-Drug2014-07-23Class II

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.

Hospira Inc.
Hazard

Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.

Sold states
U.S. Nationwide
Affected count
47,400 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1433-201

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