FDA recall D-0153-2017

Hospira Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-11-01
Report date: 2016-11-30
Termination date: 2018-08-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

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