Health product recall

APO-AMITRIPTYLINE 10mg: NDMA Impurity

Last updated

Summary

Product
APO-AMITRIPTYLINE 10mg
Issue
Health products - Contamination
Health products - Product safety
What to 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. Contact your health care provider if you have taken a recalled product and you have concerns about your health.

Affected products

Brand Product Name Market Authorization Dosage Form Strength Lot
APO-AMITRIPTYLINE APO-AMITRIPTYLINE DIN 02403137 Tablet 10 MG PY1904

Issue

Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 48-month stability testing timepoint.

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.com
    • AA Pharma at 1-905-669-1565
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Previous recalls or alerts
Background

Depth of recall: Retailers, Wholesalers, Healthcare Establishments

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies

Apotex Inc. 
150 Signet Drive, 
Toronto, Ontario, M9L 1T9

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-72672
Media and public enquiries

Media enquiries

Health Canada
(613) 957-2983
media@hc-sc.gc.ca

Public enquiries

(613) 957-2991
1-866 225-0709
info@hc-sc.gc.ca

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