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Health Canada Health products

APO-AMITRIPTYLINE 10mg: NDMA Impurity

Issued February 7, 2023
Issue
Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 48-month stability testing timepoint.
Hazard description
Contamination - Product safety
What to 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.
Product
Product name
APO-AMITRIPTYLINE 10mg
Reference
ID
RA-72672