Health Canada

Health Canada

September 05, 2013 09:17 ET

Precautionary Recall of Birth Control Product: Esme-28

OTTAWA, ONTARIO--(Marketwired - Sept. 5, 2013) -

The issue:

Esme-28 (DIN 02388146), an oral contraceptive (birth control product), is being voluntarily recalled from the Canadian market by Mylan Pharmaceuticals. This action is further to their recall of a different birth control product, Freya-28, which was recalled on August 27, 2013, after one package was found to contain a placebo pill in place of an active pill.

Health Canada has been advised by Mylan Pharmaceuticals that they have been unable to rule out the possibility that Esme-28 was impacted by the same packaging issue involving Freya-28. Therefore, as a precaution, Mylan Pharmaceuticals is expanding their recall to include Esme-28. To date, no packaging errors have been identified with Esme-28.

Packages of Esme-28 should have three rows of active (pink) pills and one row of placebo (green) pills.

Missing one or more active (pink) pills could result in reduced effectiveness for contraception, with the possibility of an unplanned pregnancy. As of August 24, 2013, no adverse reactions have been reported to Health Canada related to this issue.

Who is affected:

Canadians who have purchased or used Esme-28.

What consumers should do:

• Use a non-hormonal method of birth control (such as condoms, spermicidal foam or gel),

• Contact your health care provider for medical advice.

• Return unopened packages to your pharmacist.

• Report any adverse reactions potentially related to Esme-28 to Health Canada.

• Contact Health Canada's toll-free line at 1-800-267-9675 with questions or complaints about this product.

What Health Canada is doing:

Health Canada will continue to monitor the situation and update Canadians and health care practitioners should new information or products be identified.

Products affected:

Esme-28 (Lot # F5042001C)

The company has informed Health Canada that Esme-21 is not impacted. Packages of Esme-21 should only have 21 active (pink) pills.

Photos of the product are available at the following address: http://media3.marketwire.com/docs/HC_picE.pdf

How to report side effects of 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 social media tools.

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Contact Information

  • Media Inquiries:
    Health Canada
    (613) 957-2983

    Public Inquiries:
    (613) 957-2991
    1-866-225-0709