April 13th, 2013

Precautionary recall of additional lots of Alysena-28


Starting date: April 12, 2013
Posting date: April 12, 2013
Type of communication: Information Update
Subcategory: Drugs
Source of recall: Health Canada
Issue: Important Safety Information
Audience: General Public
Identification number: RA-26769

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.

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.
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

HEALTH CANADA COPY 3rd Recall _Letter_Alysena Final_EN1

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