Drug Litigation Newsroom

Berlex Voluntarily Recalls Ultravist

Berlex, Inc., a US affiliate of Schering AG, Germany, is voluntarily recalling all lots of its X-ray contrast agent Ultravist® Injection 370 mgI/mL (iopromide injection), as part of a worldwide recall, due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of Ultravist (150 mgI/mL, 240 mgI/mL, 300 mgI/mL). Berlex is undertaking this recall in consideration of the potential for serious safety problems if the product is administered to patients, including 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 Ultravist® Injection 370 mgI/mL for patient care and should immediately quarantine any product for return.

“Patient safety is our primary concern, and we are committed to taking the necessary steps in order to protect patients from any potential safety risks,” said Richard Nieman, MD, Vice President and Head of Medical Affairs for Berlex.

Berlex is undertaking this recall of Ultravist 370 mgI/mL due to the presence of particulate matter in conjunction with crystallization in consideration of the potential for thromboembolic safety problems if an affected product is administered to patients. On Thursday, July 20, 2006, Berlex voluntarily recalled a single lot of Ultravist® Injection 370 mgI/mL, 125 mL lot number 41500A (NDC 50419-346-12, EXP 01/2007) in the US due to the presence of particulate matter in conjunction with crystallization. Read more at fda.gov