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

Starting date:

May 23, 2014

Posting date:

May 23, 2014

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Labelling and Packaging

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-39593

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

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.

Products affected

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

What you 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.

Who is affected

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

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.

Report health or safety concerns

• 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.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

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

Images

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