Hospira Inc. has expanded a voluntary recall of propofol and Liposyn products because they may be contaminated with stainless steel particles invisible to the naked eye.
The expansion includes additional lots of both drugs that were distributed during a longer period of time than included in the original action on March 31.
The specific products included are Propofol Injectable Emulsion 1%, Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, according to a statement the company issued on May 27.
The recalled lots were distributed between December 2008 and April 2010, in the United States, Barbados, Canada, Chile, South Korea, Japan, Australia, Dominica Republic, Philippines, Puerto Rico, Uruguay, and the U.S. Virgin Islands. Recalled lots numbers include:
Propofol. All lot numbers beginning with 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 82, 83, 84, and 85 with the expiration date range of June 1, 2010-Jan. 1, 2012.
Liposyn. All lot numbers beginning with 72, 73, 74, 75, 76, 77, 78, 82, 83, 84, and 85 with the expiration date range of June 1, 2010-July 1, 2011.
Any provider who has existing inventory of the drugs should stop using them and call Stericycle, a company that will arrange to have the drugs returned to Hospira (877-884-7835).
Hospira's medical communications department is handling medical questions related to the products and the recall (800-615-0817).
To report any adverse events associated with the contaminated products, providers can fax a report to the Food and Drug Administration's MedWatch Program (800-FDA-0178) or online at www.fda.gov/medwatch.
Although the company's statement noted that there have been no reports of adverse events associated with the products, "Hospira is undertaking this recall in consideration of the potential for safety issues if the products are administered to patients. Since the 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. Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, heart attack and/or death."
The company discovered the stainless steel particles in samples that were retained for testing. "Hospira has implemented improvements to its manufacturing process and is coordinating with the FDA to begin distribution of Liposyn and propofol manufactured under the new process as soon as possible," according to the statement.