FDA recall D-0381-2015

Product

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

Reason for recall

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-12-23

Report date

2015-02-04

Termination date

2015-07-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0381-2015