This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Information update

Health Canada requests quarantine of drugs linked to Polydrug Laboratories due to data integrity concerns

Starting date:
June 24, 2015
Posting date:
June 24, 2015
Type of communication:
Information Update
Source of recall:
Health Canada
Important Safety Information, New safety information
General Public
Identification number:

OTTAWA – Health Canada has requested that Canadian importers voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Polydrug Laboratories, in Ambarnath, Maharashtra, India, due to data integrity concerns.

Health Canada is taking this interim precautionary measure to help mitigate any potential risk in light of recent findings from trusted regulatory partners that raised concerns about the reliability of data generated at this site.

At this time there is no identified risk to health, and Health Canada is not requesting a recall of any products with API from Polydrug Laboratories currently on the Canadian market.

APIs are used to make finished drug products that are sold to consumers. A quarantine will mean that Canadian importers and distributors will stop distributing products in Canada with APIs linked to this site.

Health Canada continues to review information from the trusted regulatory partners and from Canadian importers. Canadians will be updated about the list of products affected by the requested quarantine through updates on the Inspection Tracker.

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

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.

Health Canada will also engage the provinces and territories to share information about the situation.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709