Hospira of Lake Forest, Ill., is recalling certain lots of propofol injectable emulsion 1% because some containers may contain particulate matter.
For the same reason, the company also is recalling certain lots of its Liposyn intravenous fat emulsion. Hospira identified stainless-steel manufacturing equipment as the source of the particulate matter and has implemented corrective actions.
The recall affects 73 lots of propofol 1% and 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30% that begin with the lot numbers 79 and 80. Hospira distributed these lots between July and October.
Anyone with an inventory of these products should quarantine the products and call Stericycle at (866) 654-0725 to arrange for a return. Hospira Medical Communications will address medical inquiries at (800) 615-0187 between 8 a.m. and 5 p.m. CST, Monday through Friday.
Product users also may report any adverse reactions or quality problems to the Food and Drug Administration's MedWatch Program by phone at (800) FDA-1088, by fax at (800) FDA-0178, via the MedWatch Web site at www.fda.gov/medwatch, or by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
Hospira is currently manufacturing both products and has begun to ship replacements. Additional details are available from Hospira Customer Care at (877) 946-7747.