Esme-28 Oral Contraceptive Recall [Canada]

Canada HCSC RecallCanada/Ottawa: Mylan Pharmaceuticals recalls some Esme-28 Oral Contraceptives due to reduced contraception control, unplanned pregnancy hazards. HCSC:

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Additional information:Esme-28 Oral Contraceptives
Health Canada/Santé Canada (“HCSC”) reports the following Drugs are subject to this recall:

  • Esme-28, Lot #F5042001C

According to Health Canada, Esme-28 (DIN 02388146), an oral contraceptive (birth control product), is being voluntarily recalled from the Canadian market by Mylan Pharmaceuticals. This action is further to their recall of a different birth control product, Freya-28, which was recalled on August 27, 2013, after one package was found to contain a placebo pill in place of an active pill.

Health Canada has been advised by Mylan Pharmaceuticals that they have been unable to rule out the possibility that Esme-28 was impacted by the same packaging issue involving Freya-28. Therefore, as a precaution, Mylan Pharmaceuticals is expanding their recall to include Esme-28. To date, no packaging errors have been identified with Esme-28.

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

Missing one or more active (pink) pills could result in reduced effectiveness for contraception, with the possibility of an unplanned pregnancy. As of August 24, 2013, no adverse reactions have been reported to Health Canada related to this issue.

Please note: similar products have been previously recalled. To see this earlier recall, please search for “Mylan Pharmaceuticals” or “Recalls Direct RIN: 2013-2449” using the Search Box at the top of this page.


HCSC ID number: RA-35477
Recalls Direct RIN: 2013-2483
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