Berlex Voluntarily Recalls Ultravist(R) Injection 370 mgI/mL
July 31 2006 - 9:49AM
PR Newswire (US)
WAYNE, N.J., July 31 /PRNewswire-FirstCall/ -- Berlex, Inc., a US
affiliate of Schering AG, Germany, is voluntarily recalling all
lots of its X-ray contrast agent Ultravist(R) Injection 370 mgI/mL
(iopromide injection), as part of a worldwide recall, 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,
300 mgI/mL). 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 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 the necessary steps in order to protect
patients from any potential safety risks," said Richard Nieman, MD,
Vice President and Head of Medical Affairs for Berlex. Berlex is
undertaking this recall of Ultravist 370 mgI/mL due to the presence
of particulate matter in conjunction with crystallization in
consideration of the potential for thromboembolic safety problems
if an affected product is administered to patients. On Thursday,
July 20, 2006, Berlex 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
Berlex and Schering AG, Germany are investigating the situation,
the company is taking precautionary action by initiating this
recall. Berlex has informed the FDA of its actions and maintains a
close ongoing dialogue with the Agency. 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 Ultravist(R) Injection
370 mgI/mL product. Berlex is working with Capital Returns, Inc. to
facilitate the return process. Those with questions about the
return process, please call 1-800-950-5479, menu option 1.
Healthcare providers, imaging centers, wholesalers or patients with
other 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, innovative treatments in the areas of female healthcare 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/ DATASOURCE: Berlex, Inc. CONTACT:
Richard Salem, of Berlex Laboratories, +1-973-305-5260, , or
Investor Contact - Joanne Marion, of Schering Berlin Inc,
+1-973-487-2164, or Web site: http://www.berlex.com/
http://www.fda.gov/MedWatch/report.htm
http://www.fda.gov/MedWatch/getforms.htm
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