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One lot of Ortho-Cept birth control tablets recalled due to potency issues

Starting date: April 22, 2015 Type of communication: Advisory Subcategory: Drugs Source of recall: Health Canada Issue: Suspected quality concern, Product Safety Audience: General Public Identification number: RA-53059

April 22, 2015

For immediate release

Issue

Health Canada is advising consumers that Janssen Inc. is recalling one lot of Ortho-Cept tablets (28 day), an oral contraceptive, due to the potential low potency of the two active ingredients. This may result in reduced effectiveness of the product and in some cases, a possible risk of unplanned pregnancy. The risk associated with an unplanned pregnancy is higher for certain groups of women, such as those who have been advised against becoming pregnant for medical reasons or women who have been advised not to use very low dose formulations.

Product affected: Product DIN Strength Pkg format Lot number Exp. Date Ortho-Cept tablets (28 Day) 02042533 0.15 mg of desogestrel and 0.03 mg ethinyl estradiol 28-day blister pack 13DM732 Sept. 2015

What you should do

Verify the lot number of your medication to determine if you have the affected product.

If you are unable to determine the lot number of your medication, contact the pharmacy from where it was received to confirm the lot number.

Speak to your healthcare provider about an alternative oral contraceptive as Ortho-Cept is being discontinued and will no longer be available on the Canadian market.

Use another form of reliable contraception and discontinue the use of the Ortho-Cept once you are safely switched over to the alternative.

Return unopened packages to your pharmacist.

Report any adverse events to Health Canada.

Who is affected

Consumers who have purchased or used Ortho-Cept tablets (28 day), lot 13DM732.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

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.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the recall and the implementation of appropriate corrective and preventative actions by Janssen Inc. Should new information be identified, Health Canada will update Canadians.