PMS-AMITRIPTYLINE 10 mg, 25 mg, and 50 mg: NDMA and NNORT impurity
Last updated
Summary
Product
PMS-AMITRIPTYLINE 10 mg, 25 mg, and 50 mg
Issue
Health products - Contamination
What to do
Consult your health care professional if you have any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot |
|---|---|---|---|---|---|
| PMS-AMITRIPTYLINE 10 mg | PMS-AMITRIPTYLINE 10 mg | DIN 00654523 | Tablet | Amitriptyline Chlorhydrate 10 mg | 635484 638600 636906 636907 648428 648429 633439 632625 632626 633440 636905 636146 636749 634973 635485 |
| PMS-AMITRIPTYLINE 25 mg | PMS-AMITRIPTYLINE 25 mg | DIN 00654515 | Tablet | Amitriptyline Chlorhydrate 25 mg | 635435 633433 632775 635482 |
| PMS-AMITRIPTYLINE 50 mg | PMS-AMITRIPTYLINE 50 mg | DIN 00654507 | Tablet | Amitriptyline Chlorhydrate 50 mg | 634972 635465 637195 637532 |
Issue
Affected lots exceed the interim acceptable intake limit for N-nitroso-nortriptyline (NNORT) or exceed the acceptable cumulative intake limit for (N-nitrosodimethylamine (NDMA) and 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
Pharmascience Inc.
6111 Avenue Royalmount, Montréal
Québec, H4P 2T4
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-74145
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