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Apotex Inc.
  150 Signet Drive
North York,
ON, M9L 1T9
Canada

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Apr 13, 2021
Voluntary Recall of one (1) lot of APO- AMITRIPTYLINE (Amitriptyline Hydrochloride Tablets USP) 10 mg – Lot RF0410.

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.