Home/Recalls/CANADA-62345
Health CanadaGeneral Alert

Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity

Published: February 7, 2023Recall ID: 62345Category: generalCountry: Canada
Canada
Safety AlertHealth CanadaCanadaCanada

Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity

Recalling Firm: Communications and Public Affairs Branch

Reason for Recall / Hazard

Contamination - Product safety

Product Description & Identification

Patients can continue to take their medication as prescribed by their health care provider as there is no immediate risk in continuing to take the recalled medication. Stopping amitriptyline may lead to mild withdrawal symptoms.Contact your health care provider if you have taken a recalled product and you have concerns about your health. Ask your pharmacist if you are unsure whether you are taking a recalled product.Contact the company if you have questions about the recall:Apotex Inc. via Sedgwick by calling at 1-866-875-0382, or by email at apotex3904@sedgwick.comAA Pharma at 1-905-669-1565Report any health product-related side effects or complaints to Health Canada.

Affected Products

Amitriptyline 10 mg tablets (Updated 2023-02-07 to add one recalled lot of APO-Amitriptyline)

Additional Source Details

FieldValue
N I D62345
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/amitriptyline-antidepressant-drugs-recalled-because-nitrosamine-impurity
IssueContamination - Product safety
TitleAmitriptyline antidepressant drugs recalled because of a nitrosamine impurity
ProductAmitriptyline 10 mg tablets (Updated 2023-02-07 to add one recalled lot of APO-Amitriptyline)
Archived0
CategoryDrugs
Last updated2023-02-07
OrganizationCommunications and Public Affairs Branch
What you should doPatients can continue to take their medication as prescribed by their health care provider as there is no immediate risk in continuing to take the recalled medication. Stopping amitriptyline may lead to mild withdrawal symptoms.Contact your health care provider if you have taken a recalled product and you have concerns about your health. Ask your pharmacist if you are unsure whether you are taking a recalled product.Contact the company if you have questions about the recall:Apotex Inc. via Sedgwick by calling at 1-866-875-0382, or by email at apotex3904@sedgwick.comAA Pharma at 1-905-669-1565Report any health product-related side effects or complaints to Health Canada.

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Overview

  • Recalling FirmCommunications and Public Affairs Branch
Recall Hazard Severity
Caution (Class III)
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