Ultravist (iopromide) Injection 370mgl/mL, 125 mL

Published: Fri Jul 21 00:00:00 -0400 2006

Berlex, Inc. and FDA announced a voluntary nationwide recall of a single lot (No. 41500A, Exp. 1/2007) of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, an intravenous X-ray contrast agent, due to the presence of particulate matter in conjunction with crystallization. The product was recalled because of the potential for serious safety problems if Ultravist Injection is administered to patients. These problems may include thrombosis of blood vessels, thromboembolism and injury or infarction of end organs such as heart, kidney, and brain. Hospitals, imaging centers and other healthcare facilities should not use any of the affected lot number (41500A) of Ultravist Injection 370mgL/mL, 125 mL for patient care and should immediately quarantine any product for return.