Hospira, Inc. Expands Emulsion Recall
Distributor Hospira updated a previous recall from March 31, 2010, to include additional lots of the fat emulsion in the recall.
The affected products may contain virtually invisible stainless-steel debris that do not dissolve in blood and that can restrict blood flow, cause mechanical damage to a patient's body, or lead to a stroke, respiratory, kidney, or liver failure, myocardial infarction, and/or death.
The recalled items were distributed from December 2008 to April 2010 and include the products Liposyn II 10% and 20%, Liposyn III 10%, 20%, and 30%, and the 1% propofol emulsion from lots starting with numbers:
•Propofol -- 66 to 78, 82 to 85
•Liposyn -- 72 to 78, 82 to 85
Products included in the recall have an expiration date from June 1, 2010 to Jan. 1, 2012 for the propofol and June 1, 2010 to July 1, 2011 for the fat emulsion. They were distributed to the U.S. and nine other countries.
The contamination was found during tests of the product, and the company has received no adverse event reports related to the issue, Hospira said in a prepared statement.
Customers with affected product should cease use or distribution of the emulsion, quarantine it, and arrange to return the recalled item, the company said in the brief.
Any adverse reactions experienced with the use of these products and/or quality problems may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD, 20852-9787, or on the MedWatch website.
Hospira is located in Lake Forest, Ill.