FDA recall D-314-2013

Product

Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04

Reason for recall

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-02-26

Report date

2013-05-15

Termination date

2014-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-314-2013