Apotex APO-Metformin Diabetes Medication Recall [Canada]


Canada FlagCanada/Ottawa: Logo - Apotex Inc.Apotex Inc., a Toronto, Ontario establishment, recalls certain batch/lots of the APO-Metformin ER Diabetes medication from the Canadian marketplace due to levels of Nitrosamines (“NDMA”) in excess of Canadian health regulations and consequential long-term risk of certain forms of Cancer, all serious health and safety hazards.

HCSC: http://ht.ly/O6Bt30qfPEy

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72287a-eng.php

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

  • Apotex Inc. branded APO-Metformin ER (Metformin Hydrochloride Extended-Release Tablets), sold with a DIN of 02305062 at 500 mg dosage with the following batch/lots and expiry codes:
    • Batch/lot: NV3242 with an expiry date of 04/2020
    • Batch/lot: NV3244 with an expiry date of 04/2020
    • Batch/lot: NV3245 with an expiry date of 04/2020
    • Batch/lot: NV3243 with an expiry date of 04/2020
    • Batch/lot: NV3247 with an expiry date of 04/2020
    • Batch/lot: NV3248 with an expiry date of 04/2020
    • Batch/lot: PX5334 with an expiry date of 01/2021
    • Batch/lot: PX5335 with an expiry date of 01/2021

According to Health Canada, Apotex has recalled eight (8) lots of its 500 mg Extended Release Metformin tablets (“APO-Metformin ER”) because they contain a Nitrosamine impurity called N-nitrosodimethylamine (“NDMA”) above the acceptable limit. Apotex Inc. has tested all lots of its 500 mg extended release tablets; only the affected lots are being recalled (see chart above). There are also alternative Metformin products on the Canadian market manufactured by other companies.

You should not stop taking your Metformin medication without first discussing options with your physician or other qualified health care provider. The risks from not having adequate Diabetes treatment outweigh any possible effects of exposure to the levels of NDMA found in the recalled products. Stopping Metformin medication could lead to uncontrolled Diabetes, which can cause some serious health problems:

  • Short-terms symptoms of high blood sugar include increased urination, thirst, excessive hunger, fatigue, blurred vision, drowsiness, irritability, unintended weight loss and dizziness. Very high blood sugars can lead to effects such as vomiting, diarrhea, dehydration, confusion, agitation and coma.
  • Longer-term health impacts include heart disease, nerve problems, kidney damage, blindness and limb amputations.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning or contamination.

Please talk to your physician or other qualified health care provider to discuss treatment options if you are taking a recalled product or if you have taken a recalled product and are concerned about your health.

Disposal of this product must be in accordance with local municipal hazardous waste requirements to protect your personal safety, the local drinking water supply and the ecosystem.

If you have any further questions, comments or complaints about this recall, please contact Apotex Inc. via Stericycle ULC by calling toll-free at 1-855-853-9461 during normal business hours Eastern Standard Time, Monday to Friday.

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 Metformin, please search for “Metformin” using the Search Box at the top of this page.

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

==> To see all recalls and notifications relating to Infants and Children, please search for “children” 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:
HCSC ID number: RA-72287
Recalls Direct RIN: 12630-2020
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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