Health Canada

Health Canada

June 13, 2007 14:00 ET

Health Canada/Advisory: Certain Lots of Fraxiparine and Fraxiparine Forte Syringes Recalled

OTTAWA, ONTARIO--(Marketwire - June 13, 2007) - Health Canada is advising consumers using certain lots of Fraxiparine (0.6 ml) and Fraxiparine Forte (0.8 ml) pre-filled glass syringes of a recall of the products because the syringes may crack or break which could lead to health risks for patients. Patients are advised to contact their physician to obtain another suitable product but should not discontinue their medication before consulting their health care provider.

Fraxiparine and Fraxiparine Forte are pre-filled syringes used to prevent or treat thromboembolic disorders such as blood clots and deep vein thrombosis; the product may also be used for certain heart conditions.

While most patients using Fraxiparine are treated in hospitals, some patients may use the product at home. The manufacturer of the syringes, GlaxoSmithKline Inc. is recalling the products. The manufacturer may be listed as Sanofi-Synthelabo Canada Inc. on the affected product lots. Patients with product affected by the recall should return it to their pharmacist.

The lot numbers can be found on the label and on the individual syringe package. The following lots in Canada were affected:



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Product Lot number
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Fraxiparine (0.6 ml) 3359
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Fraxiparine Forte (0.8 ml) 1071
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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.

To date, no complaints have been received in Canada related to these lots. To report a suspected adverse reaction to this health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345

Facsimile: 1-866-678-6789

CADRMP

Marketed Health Products Directorate

Email: cadrmp@hc-sc.gc.ca

The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect Canada area (www.healthcanada.gc.ca/medeffect) of the Health Canada Web site.

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Contact Information

  • Media Enquiries:
    Health Canada
    Alastair Sinclair
    613-957-1803
    or
    Public Enquiries:
    613-957-2991
    1-866-225-0709