Canadian Recall: Birth control product recall: Freya-28

Starting date:
August 27, 2013

Posting date:
August 27, 2013

Type of communication:
Advisory

Subcategory:
Drugs

Source of recall:
Health Canada

Issue:
Product Safety

Audience:
General Public

Identification number:
RA-35315

Issue

Freya-28, an oral contraceptive (birth control product), is being voluntarily recalled from the Canadian market by Mylan Pharmaceuticals after a pharmacy reported that a placebo pill was found in place of an active pill in one package. Packages of Freya-28 should have three rows of active (white) pills and one row of placebo (green) pills.

Missing one or more active (white) pills could result in reduced effectiveness for contraception, with the possibility of an unplanned pregnancy. As of August 27, 2013, there had been no adverse reactions reported to Mylan Pharmaceuticals.
Products affected

Freya-28 (Lots: 3739F001B & 3739F002B)

Packages of Freya-28 should have three rows of active (white) pills and one row of placebo (green) pills.

What you should do

Consult your healthcare practitioner with any questions or concerns regarding the use of oral contraceptives, especially Freya-28.

Use a non-hormonal method of birth control (such as condoms, spermicidal foam or gel) until another oral contraceptive can be obtained.

Return unopened packages to their pharmacist.

Report any adverse reactions potentially related to Freya-28 to Health Canada.

Contact Health Canada’s toll-free line at 1-800-267-9675 with questions or complaints about this product.

Who is affected

Canadians who have purchased or used these products.

Report health or safety concerns

Call toll-free at 1-866-234-2345

Public Enquiries
(613) 957-2991
1-866 225-0709