FDA recall D-1382-2012

Hospira, Inc. · Class II · drug

Product

Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.

Reason for recall

Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2012-04-11
Report date: 2012-06-20
Termination date: 2013-06-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1382-2012