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Health Canada Health products

ELAVIL 10mg: NDMA impurity

Issued January 26, 2022
Issue
Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 36-month stability testing timepoint.
Hazard description
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 1-888-266-7914, or by email at apotex5117@sedgwick.com AA Pharma at 1-905-669-1565 Report any health product-related side effects or complaints to Health Canada.
Product
Product name
Elavil 10mg
Reference
ID
RA-63855