At Health Canada's request, Canadian importers have agreed to quarantine health products made with active pharmaceutical ingredients (APIs) from Indian drugmaker Sri Krishna Pharmaceuticals, 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.
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 is not requesting a recall of any of the products.
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