Press Center

Date: 02/01/2023
Voluntary Recall of one (1) lot of APO-AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets USP) 10 mg - Lot PY1904.

Apotex has initiated a voluntary Type I recall to the Pharmacy Level for one lot (PY1904) of “APO-AMITRIPTYLINE 10 mg (Amitriptyline Hydrochloride Tablets USP)”. This recall is being initiated due to this one lot (PY1904) in which the acceptable intake limit for N-nitrosodimethylamine (NDMA), as established by Health Canada, has been exceeded at the 48-month stability testing timepoint. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. 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 Tablets USP) patients may contact Apotex by calling 1-800-667-4708 or 416-401-7780 (follow prompts), by email at drug.safety@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.