Advisory
2006-27
May 12, 2006
For immediate release
One lot of Minitran Transdermal System 0.6 mg/hr (nitroglycerin) recalled by the manufacturer
OTTAWA - 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.
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.
-30-
Media Inquiries:
Christopher Williams
Health Canada
(613) 946-4250
Public Inquiries:
(613) 957-2991
1-866 225-0709
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