APO-AMITRIPTYLINE 10mg: NDMA impurity
Last updated
Summary
Product
APO-AMITRIPTYLINE 10mg
Issue
Health products - 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. 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 |
|---|---|---|---|---|---|
| Apotex | APO-AMITRIPTYLINE 10mg | DIN 02403137 | Tablet | AMITRIPTYLINE HYDROCHLORIDE 10mg | PY1832 |
Issue
| Affected lots exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 36-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 1-888-266-7914, 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.
Additional information
Previous recalls or alerts
Background
Depth of distribution:
| Wholesalers, Retailers, Healthcare Establishments |
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
|
Apotex Inc. Toronto, ON Canada M9L 1T9 |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-63849
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