Voluntary Recall of one (1) lot of APO- AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets USP) 10 mg – Lot RF0410.
Apr 13, 2021
Public Communication Important Safety Information on APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets USP) 10 mg – Lot RF0410. |
Date: 04/13/2021
Voluntary Recall of one (1) lot of APO- AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets USP) 10 mg – Lot RF0410.
Apotex has initiated a voluntary Type I recall to the Pharmacy Level for one lot (RF0410) of “APO-AMITRIPTYLINE 10 mg (Amitriptyline Hydrochloride Tablets USP)”. This recall is being initiated due to this one lot (RF0410) in which the acceptable intake limit for N-nitrosodimethylamine (NDMA), as established by Health Canada, has been exceeded. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Consumers should continue taking their Amitriptyline drugs, as the risks from not having adequate treatment far outweigh any possible effects of exposure to the levels of NDMA seen in the recalled products. The details for the lot being recalled is listed below:
PRODUCT |
DIN |
STRENGTH |
SIZE/FORMAT |
LOT |
EXP. DATE (mm/yyyy) |
---|---|---|---|---|---|
APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets USP) |
02403137 |
10 mg |
1000 BTL |
RF0410 |
05/2024 |
APO-AMITRIPTYLINE (Amitriptyline hydrochloride) is indicated in the treatment and management of depressive illness of psychotic or endogenous nature and in selected patients with neurotic depression, and is also of value in alleviating the anxiety component of depression. As with other tricyclic antidepressants, APO-AMITRIPTYLINE may precipitate hypomanic episodes in patients with bipolar depression. These drugs are not indicated in mild depressive states and depressive reactions.
To report a suspected adverse reaction associated with the use of APO-AMITRIPTYLINE (Amitriptyline hydrochloride USP) patients may contact Apotex by calling 1-800-667-4708 (follow prompts), by email at drugsafety@apotex.com or by fax at 1-866-429-9133 or 416-401-3819.
Patients may also report any suspected adverse reactions associated with the use of health products to Health Canada by calling toll free at 1-866-234-2345 or by visiting MedEffect Canada's Web page on Adverse Reaction Reporting https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax.
Media inquries
Have a question for our media team? Fill out our inquiries form, and we’ll get back to you as soon as possible.
Latest news
-
Jul 2, 2025
Apotex receives Health Canada approval for Aflivu™, a biosimilar to Eylea®, available in pre-filled syringe and vial formats
Apotex Inc., the Canadian-based global health company, today announced that Health Canada has approved Aflivu™ (aflibercept), a biosimilar to Eylea®, indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema secondary to central or branch retinal vein occlusion, treatment of diabetic macular edema, and treatment of myopic choroidal neovascularization.
-
May 20, 2025
Apotex publishes 2024 Sustainability Report, highlighting progress and achievements in environmentally sustainable manufacturing, responsible business practices, and social impact
Apotex's 2024 Sustainability Report underscores our commitment to advancing health and unlocking new possibilities through partnerships, while championing sustainability and responsible business practices. "As we continue to execute our Journey of Health growth strategy, our focus on sustainability ensures that we are meeting the needs of patients, physicians, and pharmacists, and contributing positively to the environment and society. This report reflects our dedication to these values, and to transparency, accountability, and long-term value creation," said Allan Oberman, President & CEO, Apotex.
-
May 1, 2025
Apotex announces grant to Foundation for Mother and Child Health to promote maternal health with CAD $100,000 in annual funding
Apotex Inc. ("Apotex"), the largest Canadian-based pharmaceutical company, yesterday announced a grant through the Apotex Global Health Access Fund to the Foundation for Mother and Child Health ("FMCH") in Mumbai, India to support programs that promote maternal health and address child malnutrition.