Alesse 21 and 28 birth control pill: Packages may contain broken or smaller-than-normal pills, which may reduce effectiveness in preventing pregnancy

Starting date: December 1, 2017 Type of communication: Advisory Subcategory: Drugs Source of recall: Health Canada Issue: Important Safety Information, Labelling and Packaging Audience: General Public Identification number: RA-65306

Issue

Health Canada is advising consumers and health care professionals that complaints have been received for packages of Alesse 21 (21 active pills) and Alesse 28 (21 active pills, 7 that contain no hormones). The blister packages for both contained an active (pink) pill that was roughly half the proper size.

Alesse 21 and Alesse 28 are prescription drugs used to prevent pregnancy.

Products affected

Alesse 21 and Alesse 28. The complaints involved packages from the following lots, but it is not known at this time whether the issue is isolated to these lots: Alesse 21 (DIN 02236974) Lot A2532, expires August 2018 Alesse 28 (DIN 02236975) Lot A3183, expires April 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. Examine both sides of each pill thoroughly for anything unusual before taking it (such as, a different (paler) colour, jagged edges, or the pill is broken or smaller than normal). It may not be immediately obvious from looking at the blister package that there is a problem with the pills, as the underside of the pill cannot be seen while in the blister pack.

If you have a package with an unusual pill, return it to your pharmacy for a replacement package.

Do not stop taking your birth control pills as this may result in pregnancy. If you have questions or concerns about your birth control product, talk to a health care professional, including about alternatives. Talk to a health care professional if you have any questions or concerns about your birth control product.

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.

Who is affected

Women who are currently taking Alesse 21 or Alesse 28

Health professionals who dispense these products

What industry professionals should do

Additional information for pharmacists:

Check each blister pack of Alesse 21 and Alesse 28 before dispensing it to make sure the pills look as they should.

Report any unusual packages to the company (Pfizer Canada) and to Health Canada.

Background

Broken or smaller-than-normal birth control pills may deliver a smaller dose of the active drug ingredient, which could reduce its effectiveness in preventing pregnancy.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

Health Canada is working with the company, Pfizer Canada, to determine the nature and scope of the issue. We will continue to monitor the situation and assess the need for further action. Health Canada will update consumers and health care professionals as appropriate.

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