Health Canada requests quarantine of products for Canadian market from Apotex facility in Bangalore, India

Starting date:

September 24, 2014

Posting date:

September 24, 2014

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Product withdrawal, Quality, Suspected quality concern

Audience:

General Public

Identification number:

RA-41555

• 
  Issue
• 
  Media enquiries
• 
  Public enquiries

Issue

Judgments of the Federal Court set aside import restrictions on APIPL and ARPL products, ordered a retraction of statements and declared amended terms and conditions on Apotex's Establishment Licence unlawful.

March 14, 2016: Health Canada issued a new decision which imposed no terms and conditions on Apotex’s Establishment Licences for products fabricated at Apotex Pharmachem India Pvt. Ltd. (APIPL) and Apotex Research Private Limited (ARPL). As such, products fabricated at these two sites are not subject to any import restrictions. This decision was based on all available information, including new information provided by Apotex.

OTTAWA - At Health Canada's request, Apotex Inc. will quarantine products for the Canadian market manufactured at the Apotex Research Private Limited (ARPL) facility in Bangalore, India, based on a recent import ban of products from that facility by the U.S. Food and Drug Administration (FDA).

Health Canada is gathering more information, including the reasons for the FDA's actions and the potential impact of any issues it has identified on products for the Canadian market.  The quarantine will allow the Department time to verify that products from this facility meet Canadian safety and quality requirements.

A quarantine means the company will stop distribution of products in its possession. At this time, neither Health Canada nor the FDA has requested a recall of any products from the ARPL facility. The Department will continue to keep Canadians informed as further information becomes available.

Health Canada last inspected the ARPL facility in February 2014 with an international regulatory partner. The visit resulted in a compliant rating. The FDA had issued a compliant rating to the same facility following its own inspection in 2013.

Drug production is a global business, and Health Canada works with its international regulatory partners to monitor the manufacturing practices used to make the medicines that Canadians take. Health Canada continues to work with the FDA, other trusted international regulatory partners and the company to gather more information about the situation at the Apotex ARPL facility and the products affected.

Health Canada will work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709