Berlex recalls tainted lot of Ultravist CT contrast media

July 21, 2006

Berlex initiated a nationwide recall July 20 to retrieve a single lot of Ultravist after particulate matter associated with crystallization was found in vials of the intravenous x-ray and CT contrast medium.

Berlex initiated a nationwide recall July 20 to retrieve a single lot of Ultravist after particulate matter associated with crystallization was found in vials of the intravenous x-ray and CT contrast medium.

The recall is limited to lot No. 41500A of Ultravist Injection 370 mgI/mL, 125 mL, (iopromide injection), NDC 50419-346-12. The expiration date is January 2007.

Particulate matter found in the vial poses serious safety problems, including vascular thrombosis, thromboembolism, and injury to the heart, kidney, and brain, the company said in a release.

Berlex voluntarily instigated the recall after two customers complained about vials exhibiting crystallization. An investigation was begun to determine if other lots of Ultravist were affected, the company said

Berlex customers were asked to inspect their inventories for Ultravist from the affected lot. If found, the product should be quarantined immediately to prohibit its use in medical imaging.

Berlex should be contacted at 866/237-5395 to orchestrate the return of contaminated vials. Adverse reactions or quality problems with Ultravist should be reported to the FDA's Medwatch Adverse Event Reporting program or by phone at 800/332-1088.