Archived – B. Braun Recalls Contaminated Heparin Products in Canada

Starting date:

March 20, 2008

Posting date:

March 20, 2008

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Contamination

Audience:

Healthcare Professionals, Hospitals, General Public

Identification number:

RA-110002642

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  Media enquiries
• 
  Public enquiries

Health Canada testing of heparin products marketed in Canada has identified a contaminant in products from manufacturer B. Braun Medical Inc. The Department is working with the company on its recall of the affected Canadian products from the market.

The contaminant, oversulphated chondroitin sulphate, has also been found in heparin products in the United States and Australia.

On March 11, 2008, Health Canada requested that all suppliers of heparin for sale in Canada test their heparin products using the same methodology that uncovered the contamination in the United States. Health Canada is continuing its testing of heparin products from all Canadian companies and will continue to update Canadians as needed.

Heparin acts as a blood thinner, preventing the formation of clots, and is used after surgery and in dialysis, among other uses. Health professionals should only use heparin where it is medically essential after careful weighing of the risks and benefits for each individual patient. Patients should be monitored during and immediately following heparin administration for signs of allergy or anaphylactic reaction.

Adverse reaction reports to Health Canada do not show an increase in adverse reactions, including allergic reactions, related to heparin. There was one report of an allergic adverse reaction related to heparin from January 1, 2007 to March 6, 2008.

Patients should consult their physician or pharmacist if they are using B. Braun heparin products or if they experience allergic symptoms with any heparin products. Patients should not stop use of heparin without consulting a health care practitioner.

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 report a suspected adverse reaction to heparin, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

Telephone: 1-866-234-2345

Facsimile: 1-866-678-6789

Canada Vigilance Program

Marketed Health Products Directorate

Ottawa, Ontario, AL 0701C

K1A 0K9

E-mail: CanadaVigilance@hc-sc.gc.ca

The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect™ area of the Health Canada Web site.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709