BERLEX RECALLS DIAGNOSTIC REAGENT

Berlex, a U.S. affiliate of German company Schering AG, has initiated a nationwide U.S. recall of a single lot of an intravenous X-ray contrast agent, the FDA said July 20. The recall of Ultravist Injection 370 mgI/mL (iopromide injection) has been issued "due to the presence of particulate matter in conjunction with crystallization," the FDA said. Potential adverse events related to crystallization include the formation of blood clots and injury or infarction — cell or tissue death — in major organs such as the heart, kidney or brain, the FDA noted. The company initiated the recall lot after an investigation of two customer complaints of vials that exhibited crystallization, the company said.
FDA