Home/Recalls/CANADA-63849
Health CanadaType I

APO-AMITRIPTYLINE 10mg: NDMA impurity

Published: January 26, 2022Recall ID: 63849Category: generalCountry: Canada
Canada
Safety AlertHealth CanadaCanadaCanada

APO-AMITRIPTYLINE 10mg: NDMA impurity

Recalling Firm: Drugs and health products

Reason for Recall / Hazard

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 1-888-266-7914, or by email at apotex5117@sedgwick.comAA Pharma at 1-905-669-1565Report any health product-related side effects or complaints to Health Canada.

Affected Products

APO-AMITRIPTYLINE 10mg

Additional Source Details

FieldValue
N I D63849
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/apo-amitriptyline-10mg-ndma-impurity
IssueProduct safety
TitleAPO-AMITRIPTYLINE 10mg: NDMA impurity
ProductAPO-AMITRIPTYLINE 10mg
Archived0
CategoryDrugs
Last updated2022-01-26
OrganizationDrugs and health products
Recall classType I
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 1-888-266-7914, or by email at apotex5117@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 FirmDrugs and health products
  • Risk LevelType I
Recall Hazard Severity
Caution (Class III)
Official Agency Alert

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