Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

Sanofi Pasteur recalls tuberculosis (BCG) vaccine

Starting date:
June 30, 2012
Posting date:
June 30, 2012
Type of communication:
Information Update
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-15001

Health Canada is advising Canadians that Sanofi Pasteur is voluntarily recalling all Bacille Calmette-Guérin (BCG) vaccine on the market because of problems in the manufacturing facility that Health Canada believes may have affected the vaccine quality.

BCG is used to prevent serious complications of tuberculosis (TB) infection, notably for infants and children living in First Nation and Inuit communities at high risk for tuberculosis outbreaks. It is not widely used in Canada and does not prevent TB infection in someone who has already been exposed.

Approximately 1,000 vials of the vaccine have already been kept out of circulation by Sanofi Pasteur, and roughly another 4,700 vials on the market are being immediately recalled.

The Public Health Agency of Canada is investigating options to replace the BCG vaccine. Health Canada will use all of the regulatory tools at its disposal to make a replacement vaccine available while ensuring that safety is not compromised.

For infants who will not be given the BCG vaccine due to this recall, Health Canada staff and community health care workers will continue to provide strong TB program services, ensuring measures are in place to protect children at risk of exposure to TB. Antibiotic treatments are available on the Canadian market to treat tuberculosis even in very young patients.

For those who have recently received the vaccine, the symptoms of a reaction related to the manufacturing problems would likely be mild and would occur within a few days of receiving the vaccine. They would include injection site soreness and mild irritation. Consult with your healthcare practitioner if you are concerned about your health or your child's health after receiving the BCG vaccine.

Three adverse reactions potentially linked to the recalled vaccine lots have been reported to the Public Health Agency of Canada and Health Canada, and all were the kind of mild reactions normally associated with this vaccine.

Health Canada continues to work with Sanofi Pasteur to address the issues in the manufacturing facility that lead to these actions.

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.

Advisory

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709