FDA-Drug2016-11-30Class II

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

Hospira Inc.
Hazard

Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

Sold states
Nationwide
Affected count
797,800 ampules
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0153-2017

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