Archived – Important Information on Apotex Health Products

Starting date:

September 17, 2009

Posting date:

September 17, 2009

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public

Identification number:

RA-110003010

• Media enquiries
• Public enquiries

Health Canada is informing Canadians that Apotex, a prescription drug manufacturer, has voluntarily, as a precautionary measure, recalled selected lots of three health products currently on the Canadian market. Selected lots of the following products have been voluntarily recalled by Apotex: APO-AMILZIDE (5 – 50 mg), APO-MELOXICAM (7.5 and 15 mg) and APO-RANITIDINE (75 and 150 mg).

• APO-MELOXICAM is indicated for treatment of symptoms of rheumatoid arthritis and osteoarthritis in adults.
• APO-RANITIDINE is indicated for treatment and prevention of problems associated with excess stomach acid.
• APO-AMILZIDE is indicated for the maintenance therapy of patients with liver cirrhosis with fluid in the abdomen and swelling.

This information comes in light of Health Canada's ongoing inspections of Apotex manufacturing facilities in the Greater Toronto Area. Health Canada is also working with Apotex to undertake a thorough review of their Good Manufacturing Practices.

Good Manufacturing Practices (GMPs) are standards designed to ensure an effective overall approach to product quality control and risk management. GMPs do so by setting appropriate standards and practices for product manufacturing, testing, storage, handling and distribution. Information and guidelines on GMPs in Canada are available on the Health Canada website.

Health Canada will continue its inspections of Apotex facilities in Ontario over the coming weeks to verify if other health products are affected and to ensure the manufacturer's GMP compliance. At any time in the inspection process, should Health Canada's inspection reveal a risk to health, immediate and appropriate action will be taken to help protect the health and safety of Canadians.

Canadians taking Apotex products should consult with their health care practitioner if they have any questions or concerns.

Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at 613-957-2991, or call toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada website
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    Health Canada
    AL 0701C
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

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Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709