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

• 
  Issue
• 
  What you should do
• 
  Report health or safety concerns
• 
  Related AWRs
• 
  Media enquiries
• 
  Public enquiries
• 
  Images

Issue

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:

What you should do

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.

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.

Report health or safety concerns

• 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.

Related AWRs

Alysena 28 - Expanded (Additional lots)

2013-04-12 | Health products

Recall

Media enquiries

Health Canada

(613) 957-2983

 

Public enquiries

(613) 957-2991

1-866 225-0709

 

Images

Select thumbnail to enlarge - opens in a new window