Hospira Liposyn and Propofol Recall Due to Particulate Matter from Equipment

Hospira, Inc. has issued a recall for 85 lots of Liposyn, an intravenous nutritional supplement, and 73 lots of the sedative Propofal, as some of the containers may contain particulate matter that entered the drug from stainless steel equipment used during the manufacturing process. The particulate matter could cause a serious and potentially life-threatening injury, including a stroke, respiratory failure, kidney failure, liver failure, heart attack or death.

The Hospira Liposyn and Propofol recall was issued on November 6, for certain lots of the drug distributed between July 2009 and October 2009. Hospira indicates that they have identified the cause of the particulate matter and have taken steps to correct the manufacturing problem. To date, no reports of adverse events or injury have been linked to the use of the Hospira Propofol or Liposyn.

Liposyn is an intravenous nutritional supplement that provides essential fatty acids to patients. The recall affects Liposyn II in 10% and 20% concentrations, and Liposyn III in 10%, 20% and 30% concentrations. Propofol is a generic hypnotic agent used as an anesthetic and sedative. It is also sold under the brand name of Diprivan by AstraZeneca. The recall includes 73 lots of Hospira Propofol Injectable Emulsion 1%.

All of the recalled lots have lot numbers that begin with 79 and 80. The lots are suspected of containing particulate matter that could enter patients’ blood supply when injected. The particles do not dissolve in blood, and could impede blood flow and cause physical damage.

The particles could lead to blood clots or a pulmonary embolism, and it could cause Systemic Inflammatory Response Syndrome (SIRS), which could aggravate physical damage done by the particles. Blood clots and restricted blood flow from the particles could result in heart attack, stroke, respiratory failure, kidney failure, liver failure, heart attack or death.

Any health care professionals with the recalled medications in their inventory have been advised to ensure that the contaminated Liposyn and Propofol are not used and to contact Stericycle or Hospira to return the products. Any adverse reactions should be reported to the FDA’s MedWatch adverse events reporting program at www.fda.gov/medwatch.