Hospira Propofol, Liposyn Recalled Over Particulate MatterNov 11, 2009 | Parker Waichman LLP
Hospira, Inc., 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%, as well as 73 lots of Propofol Injectable Emulsion 1% products that begin with lot numbers 79 and 80. The recall has been implemented, said the U.S. Food and Drug Administration (FDA), 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.
To date, 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.
The FDA is advising anyone in possession of an existing inventory to quarantine the product immediately and call Stericycle, toll-free, at 1-866-654-0725 to arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications, also toll-free, at 1-800-615-0187 between 8:00 a.m. and 5:00 p.m. Central Standard Time, 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 telephone, toll-free at 1-800-FDA-1088; by fax, toll-free, 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, toll-free, at 1-877-946-7747 for further details.