WAYNE, N.J., July 20 /PRNewswire/ -- Berlex, Inc. has initiated a nationwide recall of a single lot (No. 41500A) of its intravenous X-ray contrast agent, Ultravist(R) Injection 370 mgI/mL, 125 mL, (iopromide injection) NDC 50419-346-12, EXP 01/2007, due to the presence of particulate matter in conjunction with crystallization. Berlex 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.
Hospitals, imaging centers and other healthcare facilities should not use any of the affected lot number 41500A of Ultravist Injection 370mgI/mL, 125 mL for patient care and should immediately quarantine any product for return. Berlex is working closely with the FDA to communicate and coordinate this recall.
Berlex, Inc. is voluntarily recalling this lot after an investigation of two customer complaints of vials that exhibited crystallization. Berlex, Inc. immediately placed remaining inventory of Ultravist 370 mgI/125 mL, lot number 41500A on hold to prevent further distribution of product from this lot. The investigation is ongoing regarding this matter to determine whether any other lots of this product might be affected.
As is standard practice and per the Ultravist package insert, all parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, and should not be used if particulates are observed or marked discoloration has occurred.
Berlex will credit accounts for all returned products from lot number 41500A and shipping costs. Berlex is working with Capital Returns, Inc. to facilitate the return process.
Healthcare providers, imaging centers, wholesalers or patients with questions may contact the company at 1-866-BERLEX-5 or 1-866-237-5395.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to FDA's MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm ], by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500 [which may be downloaded from the FDA website at http://www.fda.gov/MedWatch/getforms.htm ] by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].
Ultravist is a nonionic, iodinated, low osmolar radiological contrast agent for intravascular administration. Introduced in Europe in 1985 and in the US in 1995, Ultravist is being used today in over 100 countries worldwide. All nonionic, iodinated contrast media currently available inhibit blood coagulation in vitro less than ionic contrast media. Therefore, meticulous intravascular administration technique is necessary to minimize thromboembolic events. As with all iodinated contrast agents, serious or fatal reactions have been associated with their use. Ultravist injection is not indicated for intrathecal use.
About Berlex, Inc.
Berlex, Inc., a US affiliate of Schering AG, Germany, (FSE: SCH; NYSE: SHR), is committed to addressing unmet medical needs through research and development in the areas of oncology, gastroenterology, women's health, diagnostics and neurology. Berlex also markets diagnostic imaging agents, innovation treatments in the areas of female health care and oncology, as well as specialized therapeutics for life-threatening and disabling diseases of the central nervous system and cardiovascular system. Berlex has business operations in New Jersey, California, and Washington. For more information please visit http://www.berlex.com .
Certain statements in this press release that are neither reported financial results nor other historical information are forward looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Berlex's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Berlex, Inc. undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.
Source: Berlex, Inc.