FDA recall D-1433-201

Hospira Inc. · Class II · drug

Product

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.

Reason for recall

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

Distribution

U.S. Nationwide

Key facts

Status: Terminated
Initiation date: 2014-06-27
Report date: 2014-07-23
Termination date: 2015-09-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

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