Apotex Alysena Birth Control Pill Recall Expands [Canada]


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Canada/Ottawa: Apotex Alysena 28 Birth Control Pill Recall [Canada]Apotex Inc., a Toronto, Ontario establishment, expands its existing recall for certain batch/lots of Alysena 28 Birth Control Pills to include all current batch/lots of both Alysena 21 and Alysena 28 Oral Contraceptives due to suspected pill damage and consequential risk of pregnancy protection failure, a serious health hazard. HCSC: http://ht.ly/RmVe30iUyba

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66158a-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Contraceptive Pills are subject to this recall:

  • Apotex Alysena 21 Birth Control Pills, sold with a drug identification number (“DIN”) of 02387875. All current batch/lot designations are subject to this recall notification.
  • Apotex Alysena 28 Birth Control Pills, sold with a drug identification number (“DIN”) of 02387883. All current batch/lot designations are subject to this recall notification.

Please consult the photograph above for details of the product’s packaging, design and retail presentation. One (1) additional image of the recalled Birth Control Pills can be found on the Web site above.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to Health Canada, Apotex has recalled all current batch/lots of Alysena 21 and Alysena 28 Birth Control Pills, after complaints about chipped pink (Active) pills in sealed blister packages were received.

Both Alysena 21 and Alysena 28 are prescription Oral Contraception drugs used to prevent Pregnancy. Alysena 21 packages contain 21 “Active” pink pills while packages of Alysena 28 contain 21 “Active” pink pills and 7 “Inactive” white pills.

In these recalled batch/lots, the Active pills that are chipped may contain less of the active drug ingredients. This may reduce Alysena’s effectiveness in preventing Pregnancy.

Health Canada suggests the following steps:

  • Check your pills before and after taking them out of the blister package. Do not consume a pill if it looks unusual (for example, it is chipped, has jagged edges or is broken). Examine both sides of each pill thoroughly before taking it. It may not be immediately obvious from looking at the blister package that there is a problem with the pills since the underside of the pill cannot be seen while locked in the blister pack.
  • If you have a package with an unusual-looking pill, return it to your pharmacy for a replacement package.
  • Do not stop taking your birth control pills as this may result in pregnancy. Talk to a health care professional if you have questions or concerns about your birth control product, including about missed doses and alternatives.
  • Report adverse events to health products to Health Canada by calling toll-free at 1-866-234-2345 or by reporting online, by mail or by fax.
  • Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675 or complete an online complaint form available here: http://healthycanadians.gc.ca/apps/radar/MD-IM-0005.08.html

Additional information for pharmacists or other healthcare professionals:

  • Check each blister pack of Alysena 21 and Alysena 28 pills before dispensing them to make sure the Contraceptives look as they should.
  • Report any unusual pills to Apotex Inc. and to Health Canada.

If you believe you have purchased or have in your possession any of the recalled Contraceptive Pills, please do not use them. Instead, kindly return the product to the pharmacy where you purchased it for a replacement package.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug adulteration. If in doubt about the safety of any drug, return it to your pharmacist or healthcare provider for refund or replacement.

Please note: the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Contraceptive Pills or Birth Control Pills, please search for “contraceptive” or more generically, “birth control” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Apotex Inc., please search for “Apotex” using the Search Box at the top of this page.

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More information about this recall:
CFIA reference number: 66158
Recalls Direct RIN: 9892-2018
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Canada [external: new window opens]:
==> http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==> http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

We welcome your feedback:
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E. & O. E.

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