2009-12-04 20:56:47 -

OTTAWA, ONTARIO -- (Marketwire) -- 12/04/09 -- Health Canada is advising consumers that Montreal-based Paladin Labs Inc., the manufacturer of the prescription asthma drug Zaditen, is recalling lot #440494, which is packaged as blisters of 14 - 1mg tablets. Lot #440494 has been found to have less of its active pharmaceutical ingredient (ketotifen) than indicated on the label. An active pharmaceutical ingredient is a substance or mixture of substances in a drug that delivers the therapeutic benefit to a patient.



Use of product from lot #440494 could result in different adverse events due to decreased effectiveness. Individuals currently stabilized on Zaditen may notice a worsening of their asthma symptoms and could also experience side effects related to an unnecessary increase in the dose of their other asthma medications.



Canadians who are taking Zaditen tablets should check the lot number found on the blister packaging. If the tablets are from lot #440494, consumers are advised not to use them and to consult their pharmacist for replacement Zaditen tablets or their physician if they have new or worsening symptoms. Unused tablets from the affected lots should be returned to the pharmacist.



Zaditen is indicated as an add-on medication in the chronic treatment of mild atopic asthmatic children and comes in tablet or syrup form. Only tablets from lot # 440494 are affected by this recall.



To date, no adverse reactions from the use of this product have been reported in Canada.



Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.



You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:



- Report online ( www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php : ) at the MedEffect(TM) Canada (www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php) section of the Health Canada website


- Call toll-free at 1-866-234-2345


- Complete a Canada Vigilance Reporting Form ( www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng .. : ) and either:

   - Fax toll-free to 1-866-678-6789

   - Mail to: Canada Vigilance Program
              Health Canada
              AL 0701D
              Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label ( www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affr .. : ) from the MedEffect(TM) Canada (www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php) section of the Health Canada website. The Canada Vigilance Reporting Form (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng ..) and the adverse reaction reporting guidelines may also be obtained via this section.



Egalement disponible en francais



Contacts:
Media Inquiries:
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866-225-0709