Voluntary Nationwide Recall: One Lot of Mirvala 28 (desogestrel and Ethinyl Estradiol Tablets, Usp) 0.150 Mg / 0.030 Mg Due to Possibility of One Placebo Pill in Place of An Active Pill
TORONTO, Sept. 30, 2021 /CNW/ - Apotex Inc. is conducting a voluntary nationwide recall of one lot of Mirvala™ 28 (Desogestrel and Ethinyl Estradiol Tablets, USP) from wholesalers, distributors, retailers, pharmacies, and consumers. The identified lot is being recalled out of an abundance of caution due to a highly detectable defect of one placebo pill (green) in place of a birth control pill (white). This product is manufactured by a 3rd party source, Laboratorios LEON FARMA, S.A. Spain.
The affected lot can be identified by following the information on the product carton and/or blister card:
Mirvala™ 28 (Desogestrel and Ethinyl Estradiol Tablets, USP 0.150 mg / 0.030 mg) is indicated for conception control. For further details, please refer to the package insert. The product is packaged as 28 tablets in a blister packet.
Patients can refer to both the Patient Information Leaflet and Product Monograph of Mirvala™ 28 (Desogestrel and Ethinyl Estradiol Tablets, USP 0.150 mg / 0.030 mg) which provide clear instruction for the management of missed tablets or missed dose. To date, there are no adverse event reports received for lot LF21272B.
The impacted lot was distributed nationwide in Canada to wholesalers, distributors and pharmacies by Apotex between December 08, 2020 and August 24, 2021. Apotex is currently notifying its affected direct account customers by sending the recall notification letter and is arranging for return of the impacted product lot.
Patients who have received the impacted lot of Mirvala™ 28 (Desogestrel and Ethinyl Estradiol Tablets, USP 0.150 mg / 0.030 mg) should return the product to a pharmacy for replacement. Additionally, patients/consumers may contact Apotex Inc. via Stericycle by calling at 1-866-534-9986 or by email firstname.lastname@example.org if they have any questions about the recall.
To report a suspected adverse reaction associated with the use of Mirvala™ 28 (Desogestrel and Ethinyl Estradiol Tablets, USP 0.150 mg / 0.030 mg) patients may contact Apotex by calling 1-800-667-4708 or 416-401-7780 (follow prompts), 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.html.
Incorrect packaging configuration
Correct packaging configuration:
SOURCE Apotex Inc.