AMITRIPTYLINE 10 & 50mg: NDMA and NNORT impurity
Last updated
Summary
Product
AMITRIPTYLINE 10 & 50mg
Issue
Health products - Contamination
What to do
Consult your health care professional if you have any health concerns.
Distribution
Quebec
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot |
|---|---|---|---|---|---|
| AMITRIPTYLINE | AMITRIPTYLINE 10mg | DIN 00370991 | Tablet | Amitriptyline Hydrochloride 10mg | 632627, 633441, 638164 |
| AMITRIPTYLINE | AMITRIPTYLINE 50 mg | DIN 00456349 | Tablet | Amitriptyline Hydrochloride 50mg | 633436 |
Issue
Affected lot exceed the acceptable cumulative intake limit for N-nitrosodimethylamine (NDMA) and N-nitroso-nortriptyline (NNORT).
What you should do
Continue taking your medication.
Not treating a condition may pose a greater health risk than potential nitrosamine exposure.
Contact your health care provider:
- to discuss treatment options if you're using a recalled product
- if you have taken a recalled product and are concerned about your health
Ask your pharmacist if you're not sure if the product you're taking has been recalled.
Additional information
Background
Depth of recall: Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
|
Pro Doc Ltée 2925 boul. Industriel, Laval, QC, H7L 3W9 |
Published by
Health Canada
Audience
General public
Healthcare
Industry
Distribution
Quebec
Recall class
Type I
Identification number
RA-74143
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