Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity
CanadaAmitriptyline antidepressant drugs recalled because of a nitrosamine impurity
Recalling Firm: Communications and Public Affairs Branch
Motivo del Retiro / Peligro
TranslatedContamination - Product safety
Descripción del Producto e Identificación
TranslatedPatients 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.comAA Pharma at 1-905-669-1565Report any health product-related side effects or complaints to Health Canada.
Productos Afectados
TranslatedAmitriptyline 10 mg tablets (Updated 2023-02-07 to add one recalled lot of APO-Amitriptyline)
Additional Source Details
| Field | Value |
|---|---|
| N I D | 62345 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/amitriptyline-antidepressant-drugs-recalled-because-nitrosamine-impurity |
| Issue | Contamination - Product safety |
| Title | Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity |
| Product | Amitriptyline 10 mg tablets (Updated 2023-02-07 to add one recalled lot of APO-Amitriptyline) |
| Archived | 0 |
| Category | Drugs |
| Last updated | 2023-02-07 |
| Organization | Communications and Public Affairs Branch |
| 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.comAA Pharma at 1-905-669-1565Report any health product-related side effects or complaints to Health Canada. |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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