Berlex Issues Nationwide Recall of a Single Lot of Ultravist(R) Injection 370 mgI/mL, 125 mL in the U.S.
July 20 2006 - 7:31PM
PR Newswire (US)
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 50419-246-12, 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]. About Ultravist 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.
DATASOURCE: Berlex, Inc. CONTACT: Media, Kimberly Wix of Berlex
Laboratories, +1-973-305-5258, , or Investor Contact, Joanne Marion
of Schering Berlin Inc., +1-973-487-2164, , both of Berlex, Inc.
Web site: http://www.berlex.com/
http://www.fda.gov/MedWatch/report.htm
http://www.fda.gov/MedWatch/getforms.htm
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