Schering voluntarily recalls Ultravist® Injection 370 mgI/ml
Recall does not affect other Ultravist® concentrations
Root cause analysis is under way
Berlin, July 31, 2006, Schering AG, Germany (FSE: SCH, NYSE: SHR) is voluntarily recalling its X-ray contrast agent Ultravist® Injection 370 mgI/ml (iopromide injection) due to the potential that particulate matter in conjunction with crystallization may be present in the product.
This recall does not include other concentrations of Ultravist (150 mgI/ml, 240 mgI/ml, 300mgI/ml). Production of Ultravist 370mgI/ml in China and South Korea is not affected, and domestic supply in these two countries will continue. In Japan, only Proscope® 370mgI/ml, in Spain, also Clarograf® 370 mgI/ml is affected*.
Hospitals, imaging centers and other healthcare facilities should not use any Ultravist® Injection 370 mgI/ml for patient care and should immediately quarantine any product for return.
“Patient safety is our primary concern, and we are committed to taking necessary steps in order to protect patients from any potential safety risks,” said Dr. Karin Dorrepaal, member of the Executive Board of Schering AG, responsible for Diagnostic Imaging.
Schering is undertaking this recall of Ultravist 370 mgI/ml due to the possible presence of particulate matter in conjunction with crystallization in consideration of the potential for thromboembolic safety problems if the product is administered to patients.
On Thursday, July 20, 2006, Berlex, Inc., the U.S. affiliate of Schering AG, Germany, voluntarily recalled a single lot of Ultravist® Injection 370 mgI/ml, 125 ml lot number 41500A (NDC 50419-346-12, EXP 01/2007) in the U.S. due to the presence of particulate matter in conjunction with crystallization.
While Schering is investigating the situation it is taking precautionary action and removing the concerned lots of this product. Berlex has informed the FDA of its actions and maintains a close ongoing dialog with the agency. Authorities in other countries have also been informed by Schering.
As is standard practice, 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.
*Proscope 370 mgI/ml is the trade name of Ultravist 370 mgI/ml in Japan, Clarograf 370 mgI/ml is also the trade name of Ultravist 370 mgI/ml in Spain.
Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology&Andrology, Oncology, Diagnostic Imaging as well as Specialized Therapeutics for disabling diseases. As a global player with innovative products, Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life:
making medicine work
This press release has been published by Corporate Communication of Schering AG, Berlin, Germany.
After the proposed offer of cash compensation by Dritte BV GmbH, a wholly owned subsidiary of Bayer Aktiengesellschaft, in connection with the planned domination and profit and loss transfer agreement between Dritte BV GmbH and Schering Aktiengesellschaft, is made available to Schering Aktiengesellschaft shareholders, Schering Aktiengesellschaft will file with the U.S. Securities and Exchange Commission a solicitation/recommendation statement on Schedule 14D-9 with respect to the offer of cash compensation. Holders of ordinary shares and American depositary shares of Schering Aktiengesellschaft are advised to read such solicitation/recommendation statement when it becomes available because it will contain important information. Holders of ordinary shares and American depositary shares of Schering Aktiengesellschaft will be able to obtain such solicitation/recommendation statement and other filed documents when they become available free of charge at the U.S. Securities and Exchange Commission’s website (http://www.sec.gov) and at Schering Aktiengesellschaft’s website (http://www.schering.de).
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 Schering AG’s plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG 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
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