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Health Canada announces voluntary recall of BCG vaccine by Sanofi Pasteur

Health Canada has announced that Sanofi Pasteur is voluntarily recalling Bacille Calmette-Guerin (BCG) vaccine due to potential contamination of the product because of manufacturing issues.

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

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.

The vaccine is not widely used in Canada and does not prevent TB infection in someone who has already been exposed.

The regulator continues to work with Sanofi to tackle the issues in the manufacturing facility that lead to the recall.