FDA recall D-297-2013

Product

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reason for recall

Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-04-08

Report date

2013-05-01

Termination date

2014-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-297-2013