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One lot
of Minitran Transdermal System 0.6 mg/hr (nitroglycerin)
recalled by the manufacturer
May 12, 2006
Health Canada is advising
Canadian consumers not to use one specific
lot of Minitran Transdermal System 0.6 mg/hr nitroglycerin
patches because of a risk that users may not get
the proper dose of the drug.
The affected lot number is 050811,
with an expiry date of November 2008. The lot
number is located on the individual package. The
box the product is packaged in contains a window
through which the individual package expiry date
is visible.
Health Canada
is advising Canadian consumers not to use one
specific lot of Minitran Transdermal System 0.6
mg/hr nitroglycerin patches because of a risk
that users may not get the proper dose of the
drug.
The patch liner on units from this
lot is difficult to remove and the patches might
get folded or deformed. Patients using one of
the defective patches could miss all or part of
the scheduled dose of nitroglycerin.
Minitran Transdermal System 0.6
mg/hr nitroglycerin patches are prescribed to
prevent angina attacks in patients who have stable
angina that is associated with coronary artery
disease. The use of defective patches may cause
a change in the level of pain experienced by patients
with this disease.
A recall has been initiated by 3M
Pharmaceuticals following confirmation that a
roll of defective liner was used in production
of the affected lot. The product, distributed
Canada wide, is packed in white boxes with blue
writing. Each box contains 30 patches.
Patients who have purchased Transdermal
System 0.6 mg/hr with the lot number 050811 are
advised to return the product to the point of
sale immediately in order to obtain a box from
another lot.
Health Canada has received no reports
of adverse reactions associated with the use of
this product and continues to monitor the effectiveness
of the recall.
To report a lack of efficacy of
treatment or a suspected adverse reaction to Minitran
Transdermal System 0.6 mg/hr nitroglycerin patches,
please contact the Canadian Adverse Drug Reaction
Monitoring Program (CADRMP) of Health Canada by
one of the following methods:
Telephone: 866-234-2345
Facsimile: 866-678-6789
CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture,
AL 0701C
Ottawa, Ontario K1A 0K9
Email: cadrmp@hc-sc.gc.ca
To obtain further information about
the recall of Minitran Transdermal System 0.6
mg/hr nitroglycerin patches lot number 050811,
please call 3M Pharmaceuticals Customer Service
at 1-800-410-6880.
Consumers requiring more information
on this advisory can contact the Health Canada
public inquiries line at (613) 957-2991, or toll
free at 1-866-225-0709.
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