FDA recall D-887-2013

Hospira Inc. · Class II · drug

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, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33

Reason for recall

Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-05-25
Report date: 2013-08-21
Termination date: 2014-09-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-887-2013