Customer Care: (877) 946-7747
Medical Communications: (800) 615-0187
Web site: hospira.com
Hospira, Inc. has recalled 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.