Advisory - Hypertension drug PMS-Losartan-HCTZ recalled due to labelling error

OTTAWA, May 23, 2014 /CNW/ - The issue:

Pharmascience Inc., in consultation with Health Canada, is recalling one lot of PMS-Losartan-HCTZ due to a labelling error on the blister pack (see photo below). The printed boxes of the product show the proper dosage "Losartan-HCTZ100/25mg," while some blisters or inner packages incorrectly say "Losartan-HCTZ 100/12.5mg." The product is packaged with 100/25mg tablets. Taking more of the drug than prescribed could have serious health effects.

Who is affected:
Canadians who either have used or purchased PMS-Losartan-HCTZ 100/25mg lot number 0300804.

What consumers should do:

• If you are taking this product, check the packaging for the lot number.  If this is the affected lot, return the product to your pharmacist and obtain a replacement.
• Report any adverse events using these products to Health Canada.

What Health Canada is doing:

Health Canada is monitoring Pharmascience Inc.'s recall and will inform Canadians should there be new information, as necessary.

Background:

PMS-Losartan-HCTZ 100/25mg is a combination product of both losartan (100 mg) and hydrochlorothiazide (HCTZ, 25mg) used for the treatment of hypertension (high blood pressure). One lot is being recalled due to a labelling error on the inner package or blister.  Taking two 100/25mg tablets instead of one to obtain the correct amount of HCTZ would result in a double dose of both components (losartan and HCTZ) of this product and potential serious adverse effects. The possible risks of a double dose include hypotension (low blood pressure), fast heart rate, and depletion of electrolytes (or salts) in the body and dehydration.

Products affected:
1. PMS-Losartan-HCTZ (Lot number: 0300804).

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects of health products to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

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Image with caption: "PMS-Losartan-HCTZ (CNW Group/Health Canada)". Image available at: http://photos.newswire.ca/images/download/20140523_C9787_PHOTO_EN_40727.jpg

SOURCE: Health Canada

For further information:

Media Enquiries: 
Health Canada
[phone]

Public Enquiries:
[phone]
1-866 225-0709