FDA recall D-169-2013

Product

Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04

Reason for recall

Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-01-10

Report date

2013-03-06

Termination date

2014-10-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rocky Mount, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-169-2013