BERLEX RECALLS ALL LOTS OF X-RAY CONTRAST AGENT

Less than two weeks after recalling a single lot of its Ultravist Injection X-ray contrast agent, Berlex announced July 31 the recall of all lots worldwide.

The recall, limited to the 370-mgl/mL concentration, is based on the potential that "particulate material in conjunction with crystallization may be present in the product," according to the company. The previous recall was triggered by an investigation of two complaints of vials that showed crystallization.

Patients receiving the recalled material are potentially at risk for thrombosis of the blood vessels and injury to the heart, kidney and brain, Berlex said. It has notified the FDA and is investigating the situation.

The company reminded users, including hospitals, imaging centers and other healthcare facilities, that they should visually inspect all parenteral drug products for particulate matter and discoloration prior to administration and should not use them if particulates are observed or marked discoloration has occurred. This is standard practice and is included on the Ultravist package insert.

Berlex is a U.S. affiliate of Germany's Schering.