APO-AMITRIPTYLINE 10mg recall in Canada: NDMA impurity
In plain language
This recall involves APO-AMITRIPTYLINE 10mg tablets sold in Canada. It's being recalled because it contains an NDMA impurity that exceeds acceptable limits. Patients can continue to take their medication as prescribed, but should contact their healthcare provider with any concerns.
What to do
- Continue taking your medication as prescribed by your healthcare provider.
- Contact your healthcare provider if you have concerns about your health.
- Ask your pharmacist if you are unsure whether you are taking a recalled product.
- Contact Apotex Inc. or AA Pharma if you have questions about the recall.
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Affected products
APO-AMITRIPTYLINE 10mg
Lot: PY1904
Why this matters
Contamination from NDMA impurity
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: PY1904
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Contamination from NDMA impurity
What should consumers do?
Continue taking your medication as prescribed by your healthcare provider. Contact your healthcare provider if you have concerns about your health. Ask your pharmacist if you are unsure whether you are taking a recalled product. Contact Apotex Inc. or AA Pharma if you have questions about the recall.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Contamination from NDMA impurity
When was this product recalled?
This product was recalled on February 7, 2023.
Is the APO-AMITRIPTYLINE brand affected by this recall?
Yes, APO-AMITRIPTYLINE products are affected by this recall. This recall involves APO-AMITRIPTYLINE 10mg tablets sold in Canada. It's being recalled because it contains an NDMA impurity that exceeds acceptable limits. Patients can continue to take their medication as prescribed, but should contact their healthcare provider with any concerns.