Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Starting date:
September 11, 2018
Type of communication:
Advisory
Subcategory:
Drugs, Medical Device, Natural health products, Biologic/vaccine, Affects children, pregnant or breast feeding women, Veterinary Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-67732

Issue

Health Canada is informing Canadians that packages of certain lots of Marvelon 28 do not include day-of-the-week stickers. The stickers are meant to be applied on the blister pack containing the pills. The stickers indicate the first day of the week when the medication is started, and the weekdays that the pills should be taken. The stickers may be used by women to help them remember if they took their daily pill on a given day. Without these stickers, there may be an increased chance of missing a dose.

This issue does not impact the safety or effectiveness of the pills. Canadians should continue to take their medication as prescribed. It is important to keep track of when you take your pills to avoid missing any doses.

Merck Canada Inc. the importer of Marvelon 28, is currently working to correct this issue. Merck Canada will distribute day-of-the-week stickers to pharmacies, beginning the week of September 10. Customers who use Marvelon 28 will be able to pick up the day-of-the-week stickers at no additional cost.

What you should do

  • Take your pills as prescribed. If your package of Marvelon 28 does not include a day-of-the-week sticker, you can:
    • Keep track of your daily pill intake and consider using ways to remind yourself to take them, such as a daily alarm on a cellphone;
    • Go to your pharmacy to request day-of-the week stickers. Merck Canada Inc. will start the distribution of the stickers to Canadian pharmacies the week of September 11, 2018; or
    • Contact Merck Canada Inc. directly at 1-800-567-2594 ext. 3, or by e-mail at medinfocanada@merck.com, to request day-of-the-week stickers.
  • Talk to a health care professional if you have questions or concerns about your birth control product, including about missed doses.
  • Report adverse events related 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 take birth control pills
  • Health professionals who dispense these products

Affected products

Product Name  DIN Lot Number Expiry
Marvelon 28
Birth control pills
02042479 R000269
R014281
N032638
R006559
R000270
N023314
March 31, 2020
March 31, 2021
March 31, 2020
March 31, 2020
March 31, 2020
October 31, 2019

There is no need to return Marvelon 28 products that you currently have, since this issue does not impact the efficacy or safety of the tablet itself if taken as prescribed. Note that Marvelon 21 is not affected by this situation.

Background

Health Canada has confirmed with Merck Canada Inc. that the day-of-the-week stickers must be present in all packages of Marvelon 28.

Merck Canada Inc. has issued a letter to health care professionals to advise them of the issue and to ask them to proactively advise patients when prescribing or dispensing the product. The company will issue the day-of-week stickers to retail pharmacies starting the week of September 10, and to clinics that received samples starting the week of September 17, to include with any product already distributed.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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

What Health Canada is doing

Health Canada continues to follow up with Merck Canada Inc. to make sure that appropriate measures are taken to correct the issue.

Images

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For more information

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