Health products quarantined from two sites in India as Health Canada assesses data integrity concerns

Starting date:

December 23, 2014

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Improper Safety Mechanisms, Suspected quality concern, Product Safety, Quality

Audience:

General Public

Identification number:

RA-43061

• 
  Issue
• 
  Media enquiries
• 
  Public enquiries

Issue

At Health Canada's request, Canadian importers have agreed to quarantine health products from the following two India-based sites due to data integrity concerns:

• Dr. Reddy's Laboratories in Srikakulam, India
• IPCA Laboratories in Pithampur, India

This action comes in light of recent information from a trusted regulatory partner that raises concerns about the reliability of the laboratory data generated at these sites. Health Canada is taking this action as an interim precautionary measure to help mitigate any potential risk.

A quarantine means that the Canadian importers have agreed to stop the importation and distribution of products from these two sites. 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 active pharmaceutical ingredients (APIs) from Dr. Reddy's Laboratories as well as to finished drug products from a different IPCA Laboratories facility than is currently subject to import restrictions by Health Canada. Health Canada has compiled an initial list of products affected by the quarantine. The list will be updated as new information becomes available. To date, none of the affected products have been determined by Health Canada to be medically necessary.

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

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709