Voluntary Type II Recall for Alysena 28

Apotex manufacturer recalls birth control pills due to extra row of placebos

/ Author:  / Reviewed by: Joseph V. Madia, MD

Apotex had initiated a voluntary Type II recall to the retail and pharmacy level for Alysena™ 28 (lot LF01899A), on behalf of the fabricator, Laboratorios Leon Farma SA, due to the potential for a packaged unit to contain two rows of placebo instead of one row (14 tablets instead of 7 tablets) and two rows of active contraceptive tablets (14 tablets instead of 21 tablets) in the blister pack.

Apotex has been swift to respond to Health Canada's additional classification of Type I assigned to a proportion of the patient population associated with patients who should not get pregnant, whether for medical reasons or exposure to agents detrimental to a developing fetus (such as those on pregnancy prevention programmes while taking drugs that can cause harm to a developing fetus).

As such, and according to the product monograph, in the case of a missed dose, use a non-hormonal method of contraception as an interim measure until you speak with your pharmacist / physician and obtain medical advice.

If you have received this lot (LF01899A), we are asking those patients to speak with their pharmacist and or physician and return any units of this lot to their pharmacist.

Review Date: 
April 11, 2013