Health Canada releases lot of bladder cancer drug ImmuCyst
Published Monday, September 17, 2012 8:24AM EDT
OTTAWA, Ont. -- Health Canada has cleared for release one lot of the bladder cancer treatment ImmuCyst, a product that was being held from the market due to problems at the drug's production plant.
The lot contains 1,500 doses for patients across the country, Health Canada said in an advisory Friday.
The federal department released lot No. C4040AA after a review by its experts determined there is no direct evidence of microbial contamination in the product.
Earlier this year, Health Canada said an inspection of the Sanofi Pasteur plant in Toronto found mould in the manufacturing area of the building where ImmuCyst is made. The contamination problem was related to flooding that occurred last October.
There have been no reports of infection that might have been caused by contamination, Health Canada said Friday. Patients who receive ImmuCyst are under medical supervision and any possible adverse health effects related to mould contamination would be picked up by their health-care practitioners.
Sanofi Pasteur is temporarily suspending manufacturing in order to renovate the facility.
Patients and health-care providers are advised to contact Sanofi Pasteur toll-free at 1-800-268-4171 for any updates on product availability.