FDA recall D-66637-001

Product

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reason for recall

Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-10-11

Report date

2013-11-13

Termination date

2014-10-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66637-001