Advisory - One lot of Mirvala 28 birth control pill recalled

OTTAWA, ON, Sept. 30, 2021 /CNW/ -

Summary

Mirvala 28 - Incorrect packaging (1 green placebo pill [circled in red] in place of a white active pill) (CNW Group/Health Canada)

Mirvala 28 - Correct packaging (3 rows of white active pills and 1 row of green placebo pills) (CNW Group/Health Canada)

Mirvala 28 – Carton (English) (CNW Group/Health Canada)

Mirvala 28 – Carton (French) (CNW Group/Health Canada)

• 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.

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.

Affected products

Product	Company	DIN	UPC Code	Lot	Expiry
Mirvala 28	Apotex Inc.	02410257	771313225328	LF21272B	08/2022

What consumers 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 [email protected], if you have questions about the recall.
• Report any health product-related side effects or complaints to Health Canada.

Additional information for health professionals:

• 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.

Également disponible en français

SOURCE Health Canada

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]