Important Information - Voluntary Nationwide Recall SEASONIQUE
2025-06-04 · Teva Canada · original tevacanada.com ↗
Teva Canada Media Inquiries Teva Investor Relations Inquiries [email protected] [email protected] 1 of 3 Important Information - Voluntary Nationwide Recall SEASONIQUE (DIN 02346176) Extra Yellow Tablets - Lot 100069151 Expiry January 31, 2027 Distributed by Teva Canada Limited - Canadian Market Only [Updated June 4, 2025] Toronto, Canada (June 4, 2025) - Teva Canada Limited, with the knowledge of Health Canada, is initiating a nationwide voluntary Type I to the Patient (Consumer) level recall of one (1) lot of prescription drug SEASONIQUE Oral Contraceptive 2x91 Extended-Cycle Tablet Dispenser due to the possibility of having extra yellow tablets in tray 1 and/or 2 of the blister cards. To date, Teva Canada Limited has not received any reports of customer complaints or adverse events related to the lot being recalled. Products Subject to the Voluntary Recall The product is available in tablet presentation and is a combination birth control pill (oral contraceptive). The affected product and lot number is: Product Name Strength Size Lot # DIN UPC Expiry First Date of Sale SEASONIQUE 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol and 0.01 mg ethinyl estradiol 2x91 100069151 02346176 068510998774 31-Jan-2027 9-May-2025 The Product 2 Extended-Cycle Tablet Dispensers containing a total of 91 tablets each: Tray 1 and Tray 2 each contain a blister card with 28 light blue-green tablets Tray 3 contains a blister card with 35 tablets (28 light blue-green tablets and 7 yellow tablets) What to Do Check the lot number on the product label. Consumers who have purchased SEASONIQUE Oral Contraceptive Tablets are asked to check the lot number on the product label. If it has the lot number listed above, you are advised to return it to the pharmacy/store where you purchased it only if you have the yellow tablets in Tray 1 and/or 2 of the blister cards. If you cannot get to a pharmacy right away, you are advised to not take yellow tablets from tray 1 and/or 2 of the blister cards. You are advised not to stop taking SEASONIQUE until you have obtained a replacement or alternative product. Yellow tablets should be taken only at the end of the tray 3 of the blister card. Teva Canada Media Inquiries Teva Investor Relations Inquiries [email protected] [email protected] 2 of 3 Teva Canada Limited is notifying its distributors, retailers, and health care professionals to arrange for the return / credit of any returned recalled product lot. Distributors and retailers that have inventory of the recalled product have been advised to immediately stop distribution and isolate remaining quantities in their control and return the recalled product lots to Teva Canada Limited. Medical Questions or Side Effects This Public Communication is not intended as medical advice. To understand the implications of this information to your health, it is important that you consult a doctor or health care professional. Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of unexpected side effects in patients using SEASONIQUE Oral Contraceptive Tablets should be reported to Teva Canada Limited and/or Health Canada. Teva Canada Limited Medical Affairs & Drug Information Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 1-800-268-4127, Option 3 [email protected] Health Canada You can report any suspected adverse reactions associated with the use of health products to Health Canada: Call Toll-Free: 1-866-234-2345 Online: www.healthcanada.gc.ca/medeffect Fax Toll-Free: 1-866-678-6789 Mail: Canada Vigilance Program Marketed Health Products Directorate Health Canada, Postal Locator 0701E Ottawa, Ontario K1A 0K9 Teva Canada Media Inquiries Teva Investor Relations Inquiries [email protected] [email protected] 3 of 3 Product Images Good Product Sample: Teva Canada Limited Teva is committed to improving health by providing innovative treatments and quality generic and biosimilar medicines. We are a global company that serves over 200 million patients each day, in Canada that translates to over 175,000 prescriptions i a day filled with a Teva product. For 60 years, Teva Canada has been part of the fabric of Canadian families by providing accessible and innovative healthcare solutions including vital patient support programs. For more information visit: www.tevacanada.com Media Inquiries: Public Affairs Office Teva Canada Limited [email protected] This voluntary recall is being conducted with the full knowledge of Health Canada. i Source: IQVIA, Compuscript December 2024 MAT Tray 1 in Blister Card Tray 2 in Blister Card Tray 3 in Blister Card
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