Health product recall

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