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Arbonne Men’s Facial Moisturizer Recalled Due to Contamination

By Pharmaceutical Processing | January 30, 2013

Arbonne Men’s Facial Moisturizer Recalled Due to Contamination

Information Update

2013-15

January 30, 2013

The issue

Arbonne International Distribution Inc. is voluntarily recalling one lot (lot 043904) of its RE9 Advanced for Men Facial Moisturizer SPF 20 Sunscreen due to microbial contamination. Product testing undertaken by the company detected bacteria (Aerococcus viridans) that may pose serious health risks to people, especially those with weakened immune systems.

Who is affected

Canadians, who have purchased or used this product, especially those with weakened immune systems, such as those with HIV/AIDS.

What consumers should do:

  • Do not use RE9 Advanced for Men Facial Moisturizer SPF 20 Sunscreen.
  • Speak to your healthcare practitioner if you have used the affected product or have concerns about your health.
  • Contact Arbonne Customer Service at 1-888-ARBONNE (272-6663) for more information about the recall.
  • Report any adverse reaction you suspect may be related to this product to Health Canada (see below).

What Health Canada is doing:

Health Canada is monitoring the recall and the company’s investigation to identify and address the root cause of the contamination.

No adverse reactions involving the use of this product have been reported to Health Canada. The company has also confirmed it has received no adverse reactions reports involving the affected product to date.

Background:

The bacterium identified in the tested samples is Aerococcus viridans, whichhas been associated with infections of the blood, joints, lining of the heart and valves, and with meningitis. Potentially serious infection may result when the affected product is used in those with weakened immune systems and those with HIV/AIDS, as well as in those with damaged skin, and cuts from shaving.

The product is sold through Arbonne International Distribution’s network of independent sales consultants.

Affected Product:

RE9 Advanced for Men Facial Moisturizer SPF 20 Sunscreen

Strength: Octisalate 5.0%, Octocrylene 8.0%, Zinc Oxide 7.35%

Lot affected : 043904

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products to Health Canada:

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada’s web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools:

-30-

Media Enquiries:

Health Canada

613-957-2983

Public Enquiries:

613-957-2991

1-866-225-0709

SOURCE

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