Other safety alerts
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| Canada: Labelling error may lead to patients receiving Linessa 28 birth control pills instead of Linessa 21 |
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Health Canada is advising Canadians of a labelling error affecting one lot of Linessa 28 birth control pills on the Canadian market (lot 190056, expiry 06/2021). The English side of Linessa 28 boxes is incorrectly labelled with the eight-digit Drug Identification Number (DIN) for Linessa 21 (02272903) instead of the correct Linessa 28 DIN (02257238). The labelling error could result in a Linessa 21 patient inadvertently receiving Linessa 28 instead of Linessa 21 if the product is dispensed at the pharmacy only using the incorrect DIN as a reference.
There is a small chance that patients who were prescribed Linessa 21 but received Linessa 28 in error may not know that the last 7 green "reminder" pills in the Linessa 28 pack are inactive pills that do not contain any hormones. If patients take a "break" week (no pills) after completing a 28-day pack, as is the practice with Linessa 21, this would result in two weeks without hormone treatment, which could increase the risk of pregnancy.
The DIN error affects the English side of Linessa 28 boxes only. The French side of Linessa 28 boxes has the correct DIN. The product name "Linessa 28" is clearly and accurately printed on the box, the foil pouch and the blister pack. The labelling issue does not affect the safety or quality of Linessa pills. Patients who take Linessa 21 or Linessa 28 according to the instructions that accompany the product they received are not at an increased risk of pregnancy as a result of the labelling error.
At Health Canada's request, Aspen Pharmacare Canada Inc. has asked that pharmacies contact patients prescribed Linessa 21 to confirm that they received the correct product. According to the company, approximately 10,000 mislabelled packages from lot 190056 have been distributed nationally, starting in late May 2019. A second lot of Linessa 28 is affected by the same issue (lot 190141, expiry 06/2021) but has not yet been released on to the market. A sticker with the correct DIN will be placed on all affected Linessa 28 boxes that have not yet been distributed, to prevent patients from receiving Linessa 28 instead of Linessa 21.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../70187a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Jun 13, 2019
Issued at HKT 16:00
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