Health products from Sri Krishna Pharmaceuticals quarantined due to data integrity concerns

Starting date:
January 6, 2015
Posting date:
January 6, 2015
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-43209

Issue

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.

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.

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.

Health Canada will continue to work with international partners and Canadian importers to gather and assess information regarding the situation and take action as necessary to help protect Canadians.

Canadians should not make any changes to their medication without first consulting with a healthcare professional.

Health Canada has engaged provinces and territories to share information about the situation. The Department will also continue to keep Canadians informed as new information becomes available.

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