Product Liability

FDA recalls contaminated lots of anesthetic propofol

A brand of the anesthetic propofol is being recalled by the Food and Drug Administration (FDA) because the injectable emulsion may contain particulate matter that could potentially impede blood flow and lead to serious health issues such as stroke, respiratory failure, kidney failure, liver failure, heart attack and/or stroke. The recall includes 85 lots of Hospira, Inc. brand Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80. The affected lots were distributed between July 2009 and October 2009.

The particulate matter that may be in the recalled lots has been identified as stainless steel equipment used in the manufacturing process. Hospira is undertaking this recall in consideration of the potential for safety issues if the products are administered to patients. Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow.

Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome (SIRS). Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death. Hospira has not received any reports of adverse events related to this issue.

In July, lots of propofol injectable emulsion made by Teva Pharmaceuticals were recalled after 41 reports of propofol-treated patients experienced post-operative fever, chills and other flu-like symptoms. Adverse health events such as fever, chills, or rigors are possible with exposure to products with high endotoxin levels. Serious adverse effects, such as disseminated intravascular coagulapathy, acute respiratory distress syndrome, shock and death are possible with exposure to products with high endotoxin levels.

Propofol is also one of the drugs found at pop star Michael Jackson’s house during an investigation into the singer’s sudden death. Propofol is a powerful anesthetic and not meant for home use.

Any adverse events that may be related to propofol or any other medication should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.htm.