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Birth Control Product Recall: Freya-28

Aug 27 2013 12:00AM

Marketwire

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OTTAWA, ONTARIO -- (Marketwired) -- 08/27/13 -- The issue:

Freya-28, an oral contraceptive (birth control product), is being voluntarily recalled from the Canadian market by Mylan Pharmaceuticals after a pharmacy reported that a placebo pill was found in place of an active pill in one package. Packages of Freya-28 (see pictures below) should have three rows of active (white) pills and one row of placebo (green) pills.

Missing one or more active (white) pills could result in reduced effectiveness for contraception, with the possibility of an unplanned pregnancy. As of August 15, 2013, there had been no adverse reactions reported to Mylan Pharmaceuticals.

Who is affected:

Canadians who have purchased or used these products.

What consumers should do:

- Consult your healthcare practitioner with any questions or concerns regarding the use of oral contraceptives, especially Freya-28.

- Use a non-hormonal method of birth control (such as condoms, spermicidal foam or gel) until another oral contraceptive can be obtained.

- Return unopened packages to their pharmacist.

- Report any adverse reactions potentially related to Freya-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:

As of August 27, 2013, the manufacturer, Mylan Pharmaceuticals, had been informed of a single package of Freya-28 containing an error with a placebo pill in the place of an active pill.

The company has informed Health Canada that its other birth control product, Freya-21 is not impacted. Packages of Freya-21 should only have 21 white (active) pills.

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

Products affected:

Freya-28 (Lots: 3739F001B & 3739F002B)

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

To view images of the affected product, kindly visit the following link: http://media3.marketwire.com/docs/HPFB0827.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.

Egalement disponible en francais



Contacts:
Media Inquiries:
Health Canada
613-957-2983

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





Source: Marketwire