~ Patients advised product may have leakages ~

 

Montreal (December 14, 2001) -- Novartis Pharmaceuticals Canada Inc. today announced a nationwide voluntary recall of Transderm-Nitro^® (nitroglycerin) 0.4, a transdermal patch used for the prevention of angina pectoris. Transderm-Nitro^® 0.4 is being recalled due to reports of a "greasy film" on some patches which may indicate a leakage of nitroglycerin content.
 

The Lot number and Expiry Date are displayed on the top flap of the package as follows:
 

Transderm-Nitro^® 0.4
EXP. Fe 2003
Lot S68000
 

Novartis wishes to advise consumers that leakage of nitroglycerin patches may cause significant decrease in the effectiveness of the medication. A decreased efficacy of the patches might result in provoked angina pectoris attacks. In severe cases, heart attacks could result. Individuals who have had an increase in their angina symptoms should see a physician and discuss the recall situation with him.
 

Patients who had their prescription for Transderm-Nitro^® 0.4 filled from September 13, 2001 onwards for the above-mentioned lot are asked to return their supplies to their local pharmacy for replacement. Please note that this recall is specific to Transderm-Nitro^® 0.4 and does not apply to other strengths of Transderm-Nitro^® (i.e. Transderm-Nitro^® 0.2 and 0.6)
 

Patients who require further information regarding this recall should contact their local pharmacist or Novartis Customer Relations at 1-800-465-2244.

 

For more information:
 

Jason Jacobs
Director, Communications
Novartis Pharmaceuticals Canada Inc.
(514) 633-7872