Propofol & Liposyn Recall:
In November 2009 Hospira, Inc. issued a recall for 85 lots of Liposyn, an intravenous
nutritional supplement, and 73 lots of the sedative Propofol, 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 serious life-threatening injury, including
stroke, respiratory failure, kidney failure, liver failure, heart attack or
death.
In July of 2009 Teva Pharmaceuticals also recalled certain lots of Propofol Injectable Emulsion due to the presence of elevated endotoxin levels. These raised levels of endotoxins can have serious adverse effects such as disseminated intravascular coagulopathy, acute respiratory distress
syndrome, shock, and death.
What is Propofol?
Propofol is a short-acting, intravenously administered hypnotic agent. Its uses include the induction and maintenance of general anesthesia, sedation for mechanically ventilated adults, and procedural sedation. Propofol is also commonly used in veterinary medicine.
What is Liposyn?
Liposyn is used as a dietary supplement for patients who are unable to get enough fat in their diet, usually because of certain illnesses or recent surgery.
Hospira Propofol Recall Information:
Also 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall.
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. Hospira has identified the root cause and corrective actions have been implemented. Hospira has made the U.S. Food and Drug Administration (FDA) aware of the situation.
Anyone with an existing inventory should quarantine the product immediately and arrange for the return of these products.
Hospira Liposyn Recall Information:
Hospira, Inc. is voluntarily recalling 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30%.
Teva Propofol Recall Information:
In July of 2009 Teva Pharmaceuticals USA initiated a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.
Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Based on available information it appears that all febrile or flu-like reactions were self-limiting with spontaneous resolution.
Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.
For use as an anesthetic agent, propofol should be used only by professionals trained in the administration of general anesthesia. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of critically ill patients.
Consumers and healthcare professionals who have Teva Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their distributor.
Propofol - Liposyn Recall News Archive >>>
If you or a loved one have suffered injury or loss as a result of Propofol or Liposyn you may be entitled to compensation. Contact The Propofol Lawyers of Ennis & Ennis, P.A. today for a free case evaluation by filling out the form on this page or calling toll-free 1-800-856-6405.
