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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Hospira Issues Nationwide Voluntary Recall of Certain Lots of Liposyn™ and Propofol Products That May Contain Particulate Matter

 

Contacts: 
MediaFinancial Community
Dan Rosenberg
(224) 212-3366
Karen King
(224) 212-2711

FOR IMMEDIATE RELEASE - Nov. 6, 2009 - Lake Forest, Ill. - Hospira, Inc. (NYSE: HSP), a global specialty pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of 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 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 call Stericycle at 1-866-654-0725 to arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187 between 8 a.m. and 5 p.m. CST, Monday through Friday.

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 phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Hospira is currently manufacturing both products and has begun to ship replacement product.  Please contact Hospira Customer Care at 1-877-946-7747 for further details.

About Hospira
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com.

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