Important Information - Voluntary Nationwide Recall PrSEASONIQUE®

Teva Canada Media Inquiries Teva Investor Relations Inquires [email protected] [email protected] 1 of 3 Important Information - Voluntary Nationwide Recall PrSEASONIQUE® Oral Contraception Tablets 2x91 Extended-Cycle Tablet Dispenser (DIN 02346176) Missing Tablets - Lot 100058977 Expiry May 31, 2026 Distributed by Teva Canada Limited - Canadian Market Only [Updated May 2, 2025] Toronto, Canada (May 1, 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 PrSEASONIQUE® Oral Contraception Tablets 2x91 Extended-Cycle Tablet Dispenser due to the possibility of missing tablets. To date, Teva Canada Limited has not received any reports of 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 PrSEASONIQUE® Oral Contraception Tablets 2x91 Extended- Cycle Tablet Dispenser 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol and 0.01 mg ethinyl estradiol 2x91 100058977 02346176 068510998774 31-May-2026 25-Oct-2024 This recall does not affect any other lots of PrSEASONIQUE® Oral Contraception Tablets 2x91 Extended-Cycle Tablet Dispenser distributed by Teva Canada Limited. What to Do Check the lot number on the product label. Consumers who have purchased PrSEASONIQUE® Oral Contraception Tablets 2x91 Extended-Cycle Tablet Dispenser 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. If you cannot get to a pharmacy right away, take the next pill in the proper order as noted in the packaging until you are able to contact your pharmacist or healthcare professional. Do not stop taking PrSEASONIQUE® until you have obtained a replacement or alternative product. The Product PrSEASONIQUE® is indicated for the prevention of pregnancy and is a 91-day cyclic dosing regimen. PrSEASONIQUE® (levonorgestrel 0.15 mg/ethinyl estradiol 0.03 mg combination and ethinyl estradiol 0.01 mg) tablets are available in Extended-Cycle Tablet Dispensers. Altogether, each Tablet Dispenser holds 91 tablets consisting of 84 light blue-green tablets (each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) and 7 yellow tablets (each containing 0.01 mg ethinyl estradiol). Teva Canada Limited is notifying its distributors, retailers, and health care professionals to arrange for the return / credi t 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. Teva Canada Media Inquiries Teva Investor Relations Inquires [email protected] [email protected] 2 of 3 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 PrSEASONIQUE® Oral Contraception Tablets 2x91 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 Inquires [email protected] [email protected] 3 of 3 Product Images 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 160,000 prescriptionsi 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 May 2024 MAT

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