News release

Apotex has initiated a voluntary Type I recall to the Pharmacy Level for one lot (PY1832) of “APO-AMITRIPTYLINE 10 mg (Amitriptyline Hydrochloride Tablets USP)”. This recall is being initiated due to this one lot (PY1832) in which the acceptable intake limit for N-nitrosodimethylamine (NDMA), as established by Health Canada, has been exceeded at the 36-month stability testing timepoint. 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:

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 or 416-401-7780 (follow prompts), by email at [email protected] 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.