Health Canada takes action to restrict import of products from three Micro Labs facilities in India

Starting date:
October 27, 2014
Posting date:
October 27, 2014
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-41963

Issue

Health Canada took action today to restrict the import of health products from three Micro Labs facilities in India (Bangalore, Goa and Hosur) because of data integrity concerns identified in recent inspections by international partners.

Health Canada has compiled a list of products affected by the import restrictions. The list will be updated as new information becomes available.

The licences of companies that import products from these three facilities will be amended with terms and conditions to require independent third-party testing prior to the release of any products determined to be medically necessary onto the Canadian market. Products from these three sites that are not on the medically necessary list will not be allowed to beimported or released on to the Canadian market until Health Canada is satisfied that the data integrity issues at the plants have been addressed.

Independent testing against approved Canadian specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.

Health Canada continues to gather information about the situation at these sites from trusted international partners, including the U.S Food and Drug Administration (FDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and the World Health Organization. Based on a review of this information, the Department has significant concerns with the manner in which data are collected and reported, raising uncertainty about the quality and safety of products from these sites. Until Health Canada can be satisfied that the production processes used at these three sites meet internationally recognized good manufacturing practices (GMPs), it is taking this additional precautionary step to keep these products off the Canadian market.

Consumers should be aware that no specific safety issues have been identified with products currently on the market from the list. To date, no recall of products from these facilities has been requested by Health Canada or its regulatory partners. Health Canada has stopped imports as a temporary precautionary measure until it is satisfied of the processes followed at these sites. Consumers should not make any change to their medication without first consulting with a healthcare professional.

Health Canada continues to work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies. The Department will keep Canadians informed on further developments related to both the supply situation and the import of the products.

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