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Schering AG (Berlin, Germany) voluntarily issued a worldwide recall of all lots of its X-ray contrast agent "Ultravist Injection" 370 mgI/mL (iopromide injection) because particulate matter and crystallization may be present in the product.
Schering AG (Berlin, Germany, www.schering.de) voluntarily issued a worldwide recall of all lots of its X-ray contrast agent “Ultravist Injection” 370 mgI/mL (iopromide injection) because particulate matter and crystallization may be present in the product. The recall does not include other concentrations of Ultravist. The company is concerned that if the product is administered to patients, the contamination might cause health problems such as blood-vessel thrombosis, thromboembolism, and heart, kidney, or brain injury.
On July 20, Berlex, Inc., Schering’s US affiliate, voluntarily recalled lot number 41500A (NDC 50419-346-12, EXP 01/2007) of Ultravist Injection 370 mgI/mL in the United States because of the same concerns that prompted this week’s recall.
Schering is investigating the contamination and withdrawing the affected Ultravist lots. Berlex is keeping the US Food and Drug Administration apprised of its actions, and Schering has contacted international authorities about the recall.
The company advises hospitals, imaging centers, and other healthcare facilities not to use Ultravist Injection 370 mgI/mL for patient care and requests that those facilities immediately quarantine the product for return.