Propofol and Liposyn Recall Expanded Due to Particulate Matter

A global recall of Liposyn and Propofol made by Hospira, Inc. has been expanded to include 28 additional lots, due to the possibility that the medications may be contaminated with stainless steel particles. 

The recall, which was announced by the FDA and Hospira on May 27,  is an expansion of a prior Hospira Propofol and Liposyn recall issued on November 6, for certain lots of the drug distributed between July 2009 and October 2009.

In November 2009, the manufacturer claimed that they had identified the cause of the particulate matter and had taken steps to correct the manufacturing problem. However, the latest recall includes some medications distributed months later.

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 original recall included 73 lots of Hospira Propofol Injectable Emulsion 1%.

The expansion adds 28 new lots of Propofol and Liposyn to the list of lots recalled. The Propofol added to the recall all have lot numbers beginning with the numbers 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 82, 83, 84, and 85. They have expiration dates ranging from June 1, 2010 through January 1, 2012, and were distributed between March 2008 and April 2010. Liposyn added to the recall all have lot numbers beginning with the numbers 72, 73, 74, 75, 76, 77, 78, 82, 83, 84, and 85. They have expiration dates ranging from June 1, 2010 through July 1, 2011, and were distributed between December 2008 and April 2010.

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 could cause Systemic Inflammatory Response Syndrome (SIRS), which could aggravate physical damage done by the particles. Although Hospira indicates that there have been no injuries or adverse events reported in connection to the recalled Liposyn and Propofol, 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.