Health Canada

Health Canada

April 12, 2013 22:43 ET

Information Update: Precautionary Recall of Additional Lots of Alysena-28

OTTAWA, ONTARIO--(Marketwired - April 12, 2013) -

Editors' note: two photos are associated with this press release.

Health Canada has been informed by Apotex Inc. that the company will be recalling additional lots of Alysena-28 birth control pills as a precautionary measure while it investigates why one lot of the product contained packages with extra placebo pills in place of active pills. Packages of Alysena-28 should have three rows of pink (active) pills and only one row of white (placebo) pills (see picture below).

Canadians using this product should use a non-hormonal method of birth control, contact their health care provider for medical advice and should return unopened packages to their pharmacist.

Alysena-21, which is manufactured at the same facility, is not part of the current recall as these packages don't normally include a row of the white (placebo) pills. However, because the product is made in the same facility, Health Canada and Apotex are working together to verify this product as well. In the meantime, Canadians are encouraged to check to make sure their packages of Alysena-21 contain three rows of pink pills (see picture below).

Consumers are also strongly encouraged to report any medical problems associated with the use of Alysena-28, Alysena-21 or other health products to Health Canada.

Health Canada is committed to protecting the health and safety of Canadians. The department will continue to monitor the situation and update Canadians and health care practitioners should new information be identified.

The specific lots being recalled are:

LF01901A LF01980A LF02037A
LF01900A LF01982A LF02036A
LF01898A LF01981A LF02026A
LF01894B LF01979A
Picture of what Alysena-28 should look like - three rows of pink (active) pills and only one row of white (placebo) pills.
Picture of what Alysena-21 should look like - three rows of pink (active) pills

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.

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