BERLEX ISSUES RECALL OF INTRAVENOUS X-RAY CONTRAST AGENT

Berlex announced a voluntary nationwide recall of a single lot of its intravenous X-ray contrast agent, Ultravist Injection (iopromide injection), due to the "presence of particulate matter in conjunction with crystallization."

In the recall notice, distributed by the FDA, Berlex said the contaminants could cause serious safety problems in patients, including thrombosis of blood vessels, thromboembolism and injury or infarction of the heart, kidney and brain. The affected lot number is 41500A, with an expiration date of January 2007.

Berlex said the recall was triggered by an investigation of two customer complaints of vials that exhibited crystallization. The company said it is investigating to determine whether any other lots of the product might be affected.

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, a U.S. affiliate of Germany's Schering, markets diagnostic imaging agents, innovative treatments in female healthcare and oncology and specialized therapeutics for central nervous system and cardiovascular diseases.