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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:
- Source of recall:
- Health Canada
- Suspected quality concern, Product Safety
- General Public
- Identification number:
- What you should do
- Who is affected
- Report health or safety concerns
- Media enquiries
- Public enquiries
- What Health Canada is doing
April 22, 2015
For immediate release
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||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.
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.
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- Date modified: