OTTAWA, Ont.–At Health Canada’s request, Canadian importers have agreed to quarantine health products made with active pharmaceutical ingredients (APIs) from Sri Krishna Pharmaceuticals Ltd. in Hyderabad, India, due to data integrity concerns.
“This action comes in light of recent information from trusted regulatory partners that raised concerns about the reliability of the laboratory data generated at this site. Health Canada is taking this action as an interim precautionary measure to help mitigate any potential risk,” the agency said.
A quarantine means that the Canadian importers and distributors have agreed to stop distributing APIs or finished dosage form products containing active ingredients from this site. At this time there is no identified risk to health, and Health Canada said it is not requesting a recall of any of the products.
Health Canada’s action applies to APIs from Sri Krishna Pharmaceuticals, which are used to make finished drug products that are sold to consumers. Health Canada has compiled an initial list of products affected by the quarantine. The list will be updated as new information becomes available. Any medically necessary products will undergo appropriate testing to address any potential safety concerns.