Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity
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
| Field | Value |
|---|---|
| N I D | 62345 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/amitriptyline-antidepressant-drugs-recalled-because-nitrosamine-impurity |
| Issue | Contamination - Product safety |
| Title | Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity |
| Product | Amitriptyline 10 mg tablets (Updated 2023-02-07 to add one recalled lot of APO-Amitriptyline) |
| Archived | 0 |
| Category | Drugs |
| Last updated | 2023-02-07 |
| Organization | Communications and Public Affairs Branch |
| What you should do | 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. |