Hospira Recalls Propofol, Liposyn

Kate Traynor

BETHESDA, MD 10 November 2009—Hospira alerted health care professionals yesterday that the company has recalled dozens of lots of the sedative propofol and the i.v. nutritional supplement Liposyn that may be contaminated with metal particles.

According to the company, the particulate matter is stainless steel from equipment used in the manufacturing process.

The recall affects 73 lots of propofol 1% injectable emulsion and 85 lots of Liposyn II, 10% and 20%, and Liposyn III, 10%, 20%, and 30%, all with lot numbers beginning with the numbers 79 or 80.

According to Hospira, the lots were distributed this year between July and October.

The company stated that the metal contaminants could potentially cause an embolism if they enter the bloodstream and could also induce an adverse inflammatory response.

Hospira stated that it has not received any reports of adverse events related to the contaminated products.

Customers with the recalled lots on hand should call Stericycle at 866-654-0725 for information about returning the material. Hospira stated that it is manufacturing and shipping replacements for the recalled lots.

This is the second national propofol recall in recent months. Teva recalled two lots of endotoxin-contaminated propofol emulsion after reports that 41 patients had become ill after receiving the sedative.

ASHP's Drug Product Shortages Management Resource Center reports that propofol injection is in short supply nationwide, as is thiopental, another sedative.

The American Society of Anesthesiologists announced yesterday that it is working with FDA and ASHP to devise strategies to address the problem, including the use of alternative agents and the possible importation of anesthesia agents from abroad.