FDA recall D-1424-2014

Product

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20

Reason for recall

Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-05-16

Report date

2014-07-16

Termination date

2017-03-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1424-2014