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 (see pictures below) 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
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
Advisory

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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

What Health Canada is doing

As of August 27, 2013, the manufacturer, Mylan Pharmaceuticals, had been informed of a single package of Freya-28 containing an error with a placebo pill in the place of an active pill.

The company has informed Health Canada that its other birth control product, Freya-21 is not impacted. Packages of Freya-21 should only have 21 white (active) pills.

Health Canada will continue to monitor the situation and update Canadians and health care practitioners should new information or products, be identified.

Images

Select thumbnail to enlarge - opens in a new window