Berlex issues Ultravist recall for U.S.

Jul 20, 2006

Contrast agent provider Berlex, the U.S.-based affiliate of Berlin-based Schering, said it has initiated a U.S. recall of a single lot of its Ultravist intravenous x-ray and CT contrast agent due to the presence of particulate matter in conjunction with crystallization.

The affected lot is number 41500A of Ultravist Injection 370 mgI/mL, 125 mL, (iopromide injection) NDC 50419-246-12, EXP 01/2007. Hospitals, imaging centers, and other healthcare facilities should not use any Ultravist product from lot number 41500A, the company said.

Berlex is voluntarily recalling the lot after an investigation of two customer complaints of vials that exhibited crystallization. The firm said it immediately placed the remaining inventory of the lot in question on hold to prevent its further distribution.

The company said it 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, according to Montville, NJ-based Berlex.

Berlex said it is working closely with the U.S. Food and Drug Administration to communicate and coordinate the recall, and that an investigation is ongoing to determine whether any other lots of Ultravist might be affected.

Healthcare providers, imaging centers, wholesalers, or patients with questions may contact the company at 1-866-237-5395. Berlex said it will credit accounts for all returned products from lot number 41500A and shipping costs.

By AuntMinnie.com staff writers
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