Apotex Inc Voluntarily Recalls One Lot of Hypertension Medication Apo-Ramipril 5 mg

Apotex Inc Voluntarily Recalls One Lot of Hypertension Medication Apo-Ramipril 5 mg
 
OTTAWA, ONTARIO, Mar 19, 2012 (MARKETWIRE via COMTEX) -- The issue:

Health Canada is informing Canadians that Apotex Incorporated is conducting a voluntary recall of one lot of Apo-Ramipril 5mg Capsules used to treat hypertension (high blood pressure). The recall of Lot JR21798 was made to retail outlets across Canada.

Medication in the affected lot being recalled has been found to contain intact but empty capsules - meaning that patients taking them may not receive the dose of medication needed to treat their medical condition.

Without appropriate treatment, hypertension may lead to heart attack, stroke, kidney problems, internal bleeding and improper blood circulation. Although Apo-Ramipril is authorized for treatment of hypertension, the ingredient in this medication may also be prescribed for patients who have recently had a heart attack, or who are at high risk of heart attack or stroke.

Who is affected:

Canadians who have purchased the affected lot of Apo-Ramipril 5mg Capsules. Affected products bear the drug identification number (DIN 02251574) and are from Lot JR21798.

What consumers should do:

- Consult your healthcare practitioner if you have used this product or are concerned about your health.

- For information concerning the recall or how to return the affected product, consumers should directly contact Apotex Inc. at the following number 1-800-667-4708 or on the web.

- Report any adverse reaction potentially related to this product to Health Canada.

- Submit complaints regarding the safety, efficacy or quality of health products, to Health Canada's Inspectorate, toll-free, at 1-800-267-9675.

What Health Canada is doing:

Health Canada is monitoring the voluntary recall of the product and informing Canadians of the risk. Should Health Canada become aware that this product remains available for sale in Canada, the Department will take appropriate action.

Background:

The company became aware of the issue when a customer complained. It found the same problem in some sample products retained by the manufacturer. Apotex initiated the recall of Lot JR21798 to retail outlets. Since the capsules of Apo-Ramipril 5 mg are not transparent, it may be difficult to determine whether a capsule from the affected lot is empty.

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 to health products:

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

 

       
        --  Fax: 1-866-678-6789
       
        --  E-mail: [email protected]
       
 
www.healthcanada.gc.ca/medeffect           
        --  Mail: Canada Vigilance Program
             Marketed Health Products Directorate
             Ottawa, ON, Address Locator 0701C
             K1A 0K9
       
       

 

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

Egalement disponible en francais

 

       
        Contacts:
        Media Inquiries:
        Health Canada
        613-957-2983
       
        Public Inquiries:
        613-957-2991
        1-866-225-0709
       
       
       

 

SOURCE: Health Canada

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