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U.S. Department of Health and Human Services

Safety

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

Audience: Hospital Risk Managers, Imaging Center Administrators, other healthcare professionals
[UPDATED 07/31/2006] Berlex, Inc. and FDA announced a voluntary worldwide recall of all lots of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, due to the presence of particulate matter and crystallization with the potential for thromboembolic safety problems if an affected product is administered to patients.

[Posted 07/21/2006] 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.

[July 31, 2006 - Press Release - Berlex]
[July 21, 2006 - Press Release - Berlex]