Schering Voluntarily Recalls Ultravist(R) Injection 370 mgI/ml
July 31 2006 - 9:21AM
PR Newswire (US)
Recall Does not Affect Other Ultravist(R) Concentrations BERLIN,
July 31 /PRNewswire-FirstCall/ -- Schering AG, Germany (FSE: SCH,
NYSE: SHR) is voluntarily recalling its X-ray contrast agent
Ultravist(R) 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(R) 370mgI/ml, in Spain, also
Clarograf(R) 370 mgI/ml is affected*. Hospitals, imaging centers
and other healthcare facilities should not use any Ultravist(R)
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(R) Injection 370
mgI/ml, 125 ml lot number 41500A (NDC 50419-346-12, EXP 01/2007) in
the US 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. Your contacts at Corporate Communication:
Media Relations: Oliver Renner, T: +49-30-468-124-31, Media
Relations: Verena von Bassewitz, T: +49-30-468-19-22-06, Investor
Relations: Dr Jost Reinhard, T: +49-30-468-150-62, Pharma
Communication: Dr Claudia Schmitt, T: +49-30-468-158-05, Your
contact in the U.S.: Media Relations: Kimberly Wix, T:
+1-973-305-5258, Find additional information at:
www.schering.de/eng Legal Instruction 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 US 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 US 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 US 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. DATASOURCE: Schering
AG CONTACT: Your contacts at Corporate Communication: Media
Relations: Oliver Renner, T: +49-30-468-124-31, , Media Relations:
Verena von Bassewitz, T: +49-30-468-19-22-06, ; Investor Relations:
Dr Jost Reinhard, T: +49-30-468-150-62, ; Pharma Communication: Dr
Claudia Schmitt, T: +49-30-468-158-05, ; Your contact in the U.S.:
Media Relations: Kimberly Wix, T: +1-973-305-5258,
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