FDA recall D-1672-2012

Product

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24

Reason for recall

Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-08-03

Report date

2012-09-05

Termination date

2014-05-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1672-2012