Mylan Pharmaceuticals, the distributor of birth control pills that recalled Freya-28, has issued its second recall in as many weeks, this time for Esme-28.
"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," Canada's regulator said today. "Therefore, as a precaution, Mylan Pharmaceuticals is expanding their recall to include Esme-28."
No risk to patient safety has been identified for Esme-28 birth control pills, Mylan Pharmaceuticals says. (Health Canada) Last week, Mylan voluntarily recalled Freya-28 birth control pills across Canada after a pharmacy reported a placebo pill was misplaced in one package.
To date, no packaging errors have been identified with Esme-28.
Packages of Esme-28 should have three rows of active pills that are pink and one row of placebo pills in green.
Women who have purchased Esme-28 are advised to:
- Use a non-hormonal method of birth control (such as condoms, spermicidal foam or gel).
- Contact your health-care provider for medical advice.
- Return unopened packages to your pharmacist.
- Report any adverse reactions potentially related to Esme-2 to Health Canada.
Esme-28 birth control pills should contain three rows of active, pink pills, and one row of green, placebo pills. (Health Canada) The nationwide Esme-28 recall affects 10,295 cartons, Nina Devlin, vice president of Global Communications for Mylan, said in an email to CBC News.
The recall is by Mylan Pharmaceuticals ULC, the company's Canadian subsidiary.
"No risk to patient safety has been identified," Devlin said. "No product quality complaints have been reported regarding this lot of Mylan's Esme-28."
Esme-28 is manufactured and packaged for Mylan by Famy Care, the Canadian licence holder. Mylan is an importer and distributor of this product in Canada.
Mylan does not offer Freya-28 or Esme-28 in the U.S.
Mylan's recall follows a similar recall for another company's birth control pills.
In April, Apotex said one lot of its Alysena 28 contained an extra week of placebo pills, which reduces the effectiveness of the contraceptive and raises the possibility of unplanned pregnancy.
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