One lot of Mirvala 28 birth control pill recalled

Starting date:

September 30, 2021

Posting date:

September 30, 2021

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public, Healthcare Professionals

Identification number:

RA-76547

Last updated:
2021-09-30

Summary

• Product:
  Mirvala 28 (DIN 02410257), lot LF21272B, expiry 08/2022
• Issue:
  Apotex Inc. is recalling one lot of Mirvala 28 as the blister pack may contain a placebo (green) pill in place of an active (white) pill.
• What to do:
  If your package has a placebo (green) pill in place of an active (white) pill, return it to your pharmacy for a replacement package. Do not miss an active pill or take a placebo in place of an active pill as this could result in a pregnancy and other side effects, including spotting and irregular bleeding. Talk to a health care professional if you have questions or concerns about your birth control product, including about missed pills and back-up options.

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  Issue
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  Products affected
• 
  What you should do
• 
  What industry professionals should do
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  Media enquiries
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  Public enquiries
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  Images

Issue

Apotex Inc. is recalling one lot (LF21272B) of Mirvala 28, a prescription birth control pill, because the blister pack may contain a placebo pill (green) in place of an active birth control pill (white). 

Mirvala 28 packages contain 21 white pills (active pills that contain hormones) and 7 green placebo pills (inactive pills with no hormone). Taking the pills in the proper order, according to the instructions that accompany the product, is important for preventing pregnancy. Missing an active pill or taking a placebo in place of an active pill could result in an increased risk of a pregnancy because the pill does not contain any active hormone.  It may also cause side effects, including spotting and irregular bleeding.

Health Canada is monitoring the effectiveness of the company’s recall and the implementation of any necessary corrective and preventive actions.

Products affected

What you should do

• If your package has a placebo (green) pill in place of an active (white) pill, return it to your pharmacy as soon as possible for a replacement. If you are uncertain, consult your pharmacist.
• If you cannot get to a pharmacy right away:
  • Take the next active (white) pill in the package that you are due to take, and contact your pharmacist for a replacement as soon as possible. Do not miss an active pill or take a placebo in place of an active pill.
• If you have missed an active pill, have no more active pills and are due to take one, or if you are unsure, use a non-hormonal effective method of birth control (such as condoms) and contact your pharmacist as soon as possible.
• Packages that have the correct pills in the correct order do not need to be returned.
• Talk to a health care professional if you have questions or concerns about your birth control product, including about missed pills and back-up options.
• Contact Apotex Inc. via Stericycle by calling at 1-866-534-9986, or by email at apotex7785@sedgwick.com, if you have questions about the recall.
• Report any health product-related side effects or complaints to Health Canada.

What industry professionals should do

• Health care professionals such as pharmacists are recommended to check Mirvala 28 packages before dispensing (regardless of the lot) to make sure pills are correctly packaged.
• Report any unusual packages to the company and to Health Canada.

Media enquiries

Health Canada

(613) 957-2983
media@hc-sc.gc.ca

Public enquiries

(613) 957-2991

1-866 225-0709
hcinfo.infosc@canada.ca

Images

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