FDA recall D-0294-2015

Hospira Inc. · Class II · drug

Product

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61

Reason for recall

Lack of Assurance of Sterility; improperly crimped fliptop vials

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-12-03
Report date: 2014-12-17
Termination date: 2015-10-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0294-2015