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

OTTAWA, April 22, 2015 /CNW/ -

The 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

 

Who is affected:

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

What consumers 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.

 

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.

How to report side effects to health products 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.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Également disponible en français

 

SOURCE Health Canada

For further information: Media Enquiries: Health Canada, (613) 957-2983 ; Public Enquiries: (613) 957-2991, 1-866 225-0709


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