Certain lots of Fraxiparine and Fraxiparine Forte syringes recalled

News Release

Advisory
2007-70
June 13, 2007
For immediate release
OTTAWA - 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:

Product
Lot number

Fraxiparine (0.6 ml)
3359

Fraxiparine Forte (0.8 ml)
1071

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 of the Health Canada Web site.
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Media Inquiries:
Alastair Sinclair
Health Canada
(613) 957-1803
Public Inquiries:
(613) 957-2991
1-866 225-0709

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Certain lots of Fraxiparine and Fraxiparine Forte syringes recalled

News Release

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