Health product recall

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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