February 9, 2018
For Immediate Release
VOLUNTARY NATIONWIDE RECALL: ONE LOT OF ALYSENA™ 28 (Levonorgestrel and Ethinyl Estradiol tablets, USP 100 mcg/20 mcg) DUE TO POSSIBILITY OF BROKEN/CHIPPED TABLETS
Toronto, Ontario: Apotex Inc. announced today that it is conducting a voluntary nationwide recall of one lot of ALYSENA™ 28 (Levonorgestrel and Ethinyl Estradiol tablets, USP 100 mcg/20 mcg), UPC number 771313219914 and DIN number 02387883 from wholesalers, distributors, retailers, pharmacies, and patients. The impacted lot of ALYSENA™ 28 (Levonorgestrel and Ethinyl Estradiol tablets, USP 100 mcg/ 20 mcg) may contain chipped or broken tablets.
The affected ALYSENA™ 28 (Levonorgestrel and Ethinyl Estradiol tablets, USP 100 mcg/ 20 mcg) lot is as follows:
The product is a birth control pill used to prevent pregnancy. For further details, please refer to the package insert. The product is packaged as 28 tablets in a blister packet.
Consumption of chipped, broken or crumbling tablets will reduce the dose of hormones, or there is a possibility that the consumer may decide not to take the broken tablet. In both cases, contraceptive reliability will be reduced thus affecting the benefit risk profile of Alysena tablets (Levonorgestrel and Ethinyl Estradiol).
The product is manufactured by a third party in Europe. The impacted lot was distributed nationwide in Canada to wholesalers and distributors by Apotex between December 22, 2017 and December 28, 2017.
Apotex will notify impacted direct account customers by sending the recall notification letter by UPS Express (international) service and is arranging for return of the impacted product lot.
Patients who have received the impacted lot of ALYSENA™ 28 (Levonorgestrel and Ethinyl Estradiol tablets, USP 100 mcg/ 20 mcg) should return the product to a pharmacy for replacement. Additionally, patients/consumers may contact Apotex Inc. via Stericycle by calling at 1-855-215-5859 or by email firstname.lastname@example.org if they have any question about the recall.
To report a suspected adverse reaction associated with the use of ALYSENA™ 28 (Levonorgestrel and Ethinyl Estradiol tablets, USP 100 mcg/ 20 mcg) patients may contact Apotex by calling 1-800-667-4708 (select prompt 2), by email at email@example.com or by fax at 1-866-429-9133 or 416-401-3819.
Patients may also report any suspected adverse reactions associated with the use of health products to Health Canada by calling toll free at 1-866-234-2345 or by visiting MedEffect Canada's Web page on Adverse Reaction Reporting https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax.
Apotex is the 7th largest generic pharmaceutical company globally (according to IMS Health) with more than 11,000 employees worldwide. With its worldwide manufacturing sites, Apotex can produce up to 25 billion dosages per year. It produces 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.