Healthcare Professionals Warned Not To Use
Certain
Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due To
Potential
Contamination
Summary
The U.S. Food and
Drug
Administration (FDA) is alerting healthcare professionals not to use
certain
intravenous (IV) bags of metronidazole, ondansetron, and ciprofloxacin
because
of potential contamination. FDA has received reports of floating matter
in IV
bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India.
Microbiological analysis identified the matter in one of the bags as a
Cladosporium mold. Molds of this type can cause infections in
susceptible patients, such as immunocompromised individuals. At this
time, FDA
is not aware of any reports of injuries due to administration of these
products.
Affected products include any metronidazole, ondansetron, and
ciprofloxacin
manufactured by Claris Lifesciences Limited and sold under the following
labels:
Claris, Sagent Pharmaceuticals, Pfizer, West-Ward
Pharmaceuticals.
Background
Metronidazole and
ciprofloxacin
are antibiotics used to treat a variety of infections. Ondansetron is an
antiemetic used to treat nausea and vomiting associated with
chemotherapy or
surgery. A complaint of white matter in a bag of metronidazole was
received, and subsequent microbiological analysis identified the matter
as a
Cladosporium mold. Molds of this type can cause infections in
susceptible patients, such as immunocompromised individuals. Another
complaint
of white matter in a bag of ondansetron was received and that bag is
currently
under analysis. Foreign matter should not be present in a sterile
injectable
product.
Recommendations
While FDA is
learning more
about the situation, healthcare professionals should NOT use and should
immediately remove from their pharmacy inventories any metronidazole,
ondansetron, and ciprofloxacin intravenous bags sold under the following
labels:
Claris
Sagent
Pharmaceuticals
Pfizer
West–Ward
Pharmaceuticals
Only metronidazole,
ciprofloxacin, and ondansetron in IV bags sold under the Claris, Sagent,
Pfizer,
and West-Ward Pharmaceuticals labels are affected. Claris is initiating a
recall
of all lots of these products. These products were all manufactured on
the same
production line.
For patients who
have received
any one of these products, clinicians are advised to stop usage
immediately and
observe patients for any signs of new infection (e.g., fevers or
chills). Clinicians are requested to report any suspected adverse events
following use of these products to FDA's MedWatch program at
1-800-332-1088 or
www.fda.gov/medwatch. On May 17,
2010, FDA posted an announcement that Sagent Pharmaceuticals, Inc. had
announced
a voluntary recall of specific lots of metronidozole injection (see
http://www.fda.gov/Safety/Recalls/ucm212302.htm). Today's
HAN Advisory announces a recall initiated by Claris covering all lots of
the
three affected products (metronidazole, ciprofloxacin, and ondansetron)
manufactured by Claris and sold under the labels Claris, Sagent,
West-Ward, and
Pfizer.
For More
Information:
FDA intends to
provide new
information when it becomes available. Clinicians with additional
questions may
contact FDA at 1-888-463-6332 or druginfo@fda.hhs.gov
Additional
information is
available at: www.fda.gov
____________________________________________________________________________________
Categories of Health
Alert
messages:
Health Alert
conveys the highest level of importance; warrants immediate action or
attention.
Health
Advisory provides
important information for a specific incident or situation; may not
require
immediate action.
Health
Update provides
updated information
regarding an incident or situation; unlikely to require immediate
action.
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