Public Advisory - Two lots of Seasonale birth control recalled due to extra placebo pills Français
Product: Seasonale (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol) (DIN 02296659)
Issue: Health products – Product quality
What to do: Do not skip doses or stop taking Seasonale. If your package contains placebo (white) pills in tray 1 or 2 of the blister cards, do not take them and return the product to your pharmacy for a replacement or alternative product. If you cannot get to a pharmacy right away, take the next active (pink) pill in the proper order as noted in the instructions until you are able to contact your pharmacist and obtain a replacement or alternative product.
Affected products
Issue
Teva Canada Ltd. is recalling two lots of Seasonale prescription birth control after receiving a complaint that a package contained an extra row of placebo (white) pills where there should be none. Taking placebo pills instead of active (pink) pills may reduce the effectiveness of the product and could lead to an unintended pregnancy.
As shown in Photo 1, Seasonale pills come packaged in a dispenser containing a 13-week (91-day) supply divided into three blister cards, each placed on its own tray:
Trays 1 and 2 each hold a blister card with 28 active (pink) pills.
Tray 3 holds a blister card with 35 pills: 28 active (pink) pills and 7 placebo (white) pills.
Photo 2 shows three blister cards as well, but the tray 2 (middle blister card) contains an extra row of placebo (white) pills where there should be none.
Seasonale should be taken daily unless otherwise directed by your prescriber to prevent pregnancy. Taking the pills in the proper order, according to the instructions that accompany the product, is important for preventing pregnancy. Taking a placebo (white) pill out of order could lead to unplanned pregnancy and other side effects, including spotting and irregular bleeding.
Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions to prevent this issue from reoccurring. The Department will inform the public if any new health risks are identified.
What you should do
Do not stop taking Seasonale. Do not skip taking any active (pink) pills until the very last row of tray 3 (which is the placebo [white] pills).
Check your package. If it contains placebo (white) pills in tray 1 or 2 of the blister cards, do not take them, and return the product to your pharmacy for a replacement or alternative product.
If you cannot get to a pharmacy right away, take the next active (pink) pill in the proper order as noted in the instructions until you are able to contact your pharmacist and obtain a replacement or alternative product.
If you are unsure whether your package contains the correct pills, talk to your pharmacist.
If you took a placebo (white) pill instead of an active (pink) pill from trays 1 or 2, or if you are unsure, you should also use another method of non-hormonal back-up contraception (such as condoms) and consult with your health care professional.
Talk to a health care professional if you have any other questions or concerns about your birth control product.
Contact Teva Canada Ltd. by calling toll-free at 1-800-268-4127, Option 3, or by email at [email protected] if you have questions about this recall.
Report any health product-related side effects or complaints to Health Canada.
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