Archive – One Lot of Minitran Transdermal System 0.6 mg/hr (Nitroglycerin) Recalled by the Manufacturer

Starting date:

May 12, 2006

Posting date:

May 12, 2006

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Dosage

Audience:

Healthcare Professionals, General Public

Identification number:

RA-110001191

• 
  Media enquiries
• 
  Public enquiries

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: 1-866-234-2345

Facsimile: 1-866-678-6789

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.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709