Alesse 21 & Alesse 28 Birth Control Pill Recall [Canada]


Canada FlagCanada/Ottawa: Alesse 21 & Alesse 28 Birth Control Pill Recall [Canada]Health Canada warns consumers, physicians and other healthcare professionals that certain batch/lots of Alesse 21 and Alesse 28 Oral Contraceptive Tablets may suffer from component breakage, risk of smaller dosage and possible failure to prevent pregnancy, all serious health and safety hazards. HCSC: http://ht.ly/yJah30h4Cyi

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/65306a-eng.php

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

  • Alesse 21 and Alesse 28 Oral Contraceptive Tablets. Although the complaints involve Alesse tablet packages from the following batch/lots, but it is not known at this time whether the issue is isolated to just these batch/lots, thus caution is urged for all current Alesse products:
    • Alesse 21 (DIN 02236974), batch/lot A2532, expires August 2018
    • Alesse 28 (DIN 02236975), batch/lot A3183, expires April 2019

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, it is advising women, doctors and the Canadian healthcare community that complaints have been received for packages of Alesse 21 (containing 21 active pills) and Alesse 28 (containing 21 active pills, and 7 that contain no active hormones). The blister packages for both contained an active (pink) pill that was roughly half the proper size. It is this “half pill” that is the source of the risk and cause of this recall.

If you believe you or a family member is taking either of these two (2) Oral Contraceptives, please following these instructions from Health Canada:

  • Check your pills before and after taking them out of the blister package. Do not consume a pill if it looks unusual or does not resemble the other pink pills in the pack. Instead, use the next “normal” sized pill and contact your pharmacist or physician for a replacement pack.
  • Examine both sides of each pill thoroughly for anything unusual before taking it (such as, a different (paler) colour, jagged edges, or the pill is broken or smaller than normal). It may not be immediately obvious from looking at the blister package that there is a problem with the pills, as the underside of the pill cannot be seen while in the blister pack.
  • If you have a package with an unusual pill, return it to your pharmacy for a replacement package.
  • Do not stop taking your birth control pills as this may result in pregnancy. If you have questions or concerns about your birth control product, talk to a health care professional, including about alternatives. Talk to a health care professional if you have any questions or concerns about your birth control product.
  • 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

If you believe you have purchased or have in your possession any of the recalled Alesse 21 and Alesse 28 Birth Control Pills, please do not use them. Instead, kindly return the product to the pharmacy where you purchased it for a full refund or replacement package.

==> In general, never stop taking your prescription medications, including the Alesse 21 and Alesse 28 Birth Control Pills, without the knowledge and approval of your personal physician or other MD familiar with your medical history, current health status and other drugs, medications and supplements you may be consuming. Failure to do so, may result in a serious drug interaction, side effect, complication, personal injury and/or death.

Please note: if you think you may have already consumed the “small” pink pill, it would be wise to consult your physician immediately to establish your pregnancy status and consider an alternative form of birth control for the next two cycles. When in doubt, ask your physician or other qualified healthcare professional what’s best for you.

If you have any questions about this recall notification, please contact Health Canada at 1-866 225-0709 or 1-613-957-2991.

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 contaminated, adulterated or mislabeled Oral Contraceptive Tablets, please search for “birth control” using the Search Box at the top of this page.

==> To see all recalls and notifications relating to Drug hazards, please search for “drug” using the Search Box at the top of this page.

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

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More information about this recall:
HCSC ID number: RA-65306
Recalls Direct RIN: 9538-2017
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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