Last month, Sanofi Pasteur recalled a tuberculosis vaccination made at its Toronto plant. Now, Health Canada says inspectors found mold in a sterile production area there, and the company has idled the plant for fixes.
But the pressing issue is ImmuCyst, a bladder cancer treatment that Sanofi Pasteur makes only in Toronto, the Canadian drug regulator said in a release. Several lots of the drug are ready to go, but before they're released for shipment, they have to be tested for quality.
"In light of the manufacturing problems at the Toronoto plant, there may be a global impact on the supply of ImmuCyst," Health Canda says, adding that it's consulting with other international regulators, including FDA.
The news comes as patients in U.S. and Canada are facing record drug shortages. Plants have shut down or slowed production to fix problems ranging from contaminated vials to broken and mixed-up pills. Coupled with increased demand for some treatments--and declining production capacity for some lower-margin drugs--the manufacturing issues have straitened supplies of key medicines, including common cancer treatments.
- get the Health Canada release
- read the United Press International story
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