Hospira's propofol injectable emulsion and Liposyn intravenous fat emulsion products recalled

Hospira has announced a nationwide voluntary recall of its Propofol Injectable Emulsion 1% and Liposyn (intravenous fat emulsion) products which include Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%. This recall is being conducted because some of the containers may contain particulate matter, primarily made up of sub-visible inert stainless steel particles. Anyone in possession of the affected lots should stop using them immediately.

The recall includes all lot numbers beginning with:
  • Propofol: 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 82, 83, 84, 85; expiration date range: June 1, 2010 through January 1, 2012
  • Liposyn: 72, 73, 74, 75, 76, 77, 78, 82, 83, 84, 85; expiration date range: June 1, 2010 through July 1, 2011
Propofol is indicated as an anesthetic agent, for use only by professionals trained in the administration of general anesthesia. Propofol is also indicated for sedation of intubated, mechanically ventilated patients in the Intensive Care Unit, for use only by professionals skilled in the management of critically ill patients. Liposyn products are intravenous fat emulsions indicated as a source of calories for patients requiring parenteral nutrition.

For more information call (800) 615-0187 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215033.htm.