APO-AMITRIPTYLINE 10mg: NDMA Impurity
Summary
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. Contact your health care provider if you have taken a recalled product and you have concerns about your health.
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
APO-AMITRIPTYLINE |
APO-AMITRIPTYLINE |
DIN 02403137 |
Tablet |
10 MG |
PY1904 |
Issue
Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 48-month stability testing timepoint.
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.com
- AA Pharma at 1-905-669-1565
- Report any health product-related side effects or complaints to Health Canada.
Additional information
Previous recalls or alerts
Background
Depth of recall: Retailers, Wholesalers, Healthcare Establishments
Details
Apotex Inc.
150 Signet Drive,
Toronto, Ontario, M9L 1T9
Media and public enquiries
Media enquiries
Health Canada
(613) 957-2983
media@hc-sc.gc.ca
Public enquiries
(613) 957-2991
1-866 225-0709
info@hc-sc.gc.ca
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