Alysena 28 birth control pill: One lot recalled due to chipped pills, which may reduce effectiveness in preventing pregnancy

Starting date:
February 9, 2018
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Quality, Important Safety Information
Audience:
General Public
Identification number:
RA-65960

Issue

Health Canada is advising Canadians that Apotex Inc. is voluntarily recalling one lot of Alysena 28 birth control pill (lot LF10133A) after complaints about chipped pink pills in sealed blister packages.

Alysena 28 is a prescription drug used to prevent pregnancy. It contains 21 “active” pink pills and 7 “inactive” white pills. Active pills that are chipped may contain less of the active drug ingredients, which may reduce Alysena’s effectiveness in preventing pregnancy.

Products affected

  • Alysena 28 (DIN 02387883), lot LF10133A, expiry date 10/2019

What you should do

  • Check your pills before and after taking them out of the blister package. Do not consume a pill if it looks unusual (for example, it is chipped, has jagged edges or is broken). Examine both sides of each pill thoroughly before taking it. It may not be immediately obvious from looking at the blister package that there is a problem with the pills, since the underside of the pill cannot be seen while in the blister pack. 
  • If you have a package with an unusual-looking pill, return it to your pharmacy for a replacement package.
  • Do not stop taking your birth control pills as this may result in pregnancy. Talk to a health care professional if you have questions or concerns about your birth control product, including about missed doses and alternatives.
  • Report adverse events to health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
  • Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

Additional information for pharmacists:

  • Check each blister pack of Alysena 28 before dispensing it to make sure the pills look as they should.
  • Report any unusual pills to the company (Apotex Inc.) and to Health Canada.

Who is affected

  • Women who are currently taking the affected product
  • Health professionals who dispense the product

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada will monitor the company's recall. Health Canada is working with Apotex Inc. to determine the scope and cause of the issue. Should additional products or lots be identified, Health Canada will take appropriate action and inform Canadians as appropriate.

Images

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