Certain lots of antidepressant drug APO-Amitriptyline recalled because of nitrosamine impurity

Starting date:
April 16, 2021
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety, Contamination
Audience:
General Public
Identification number:
RA-75413

Last updated:

Summary

  • Product: APO-Amitriptyline 10 mg tablets, DIN 02403137
  • Issue: Apotex Inc. is recalling certain lots because of a nitrosamine impurity.
  • 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.

Issue

UPDATE: April 29, 2021 – Second lot recalled due to presence of nitrosamine impurity

Apotex Inc. is recalling a second lot of APO-Amitriptyline 10 mg tablets (lot PY1831, expiry 12/2023), after testing identified NDMA, a nitrosamine impurity, above the acceptable limit. The affected products table below has been updated with information on the recall. The majority of lots tested by Apotex Inc. to date are within the acceptable limit; therefore, patients are not expected to be exposed to levels of NDMA that exceed safe levels for an extended period of time. Patients can continue to take their medication as prescribed by their health care provider and do not need to return their medication to their pharmacy (see further information below, under “What you should do”).

Should additional recalls be necessary, Health Canada will update the table below and inform Canadians.

Original Advisory: April 16, 2021 – One lot of the antidepressant drug APO-Amitriptyline recalled because of nitrosamine impurity

Apotex Inc. is recalling one lot of APO-Amitriptyline 10 mg tablets after testing identified levels of N-nitrosodimethylamine (NDMA) above what is considered acceptable if the drug were to be taken over a lifetime.  

Amitriptyline is a prescription medication indicated to treat depression and used in the management of other disorders including chronic pain.

NDMA is classified as a probable human carcinogen. This means that long-term exposure to a level above what is considered safe may increase the risk of cancer.  We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. NDMA is not expected to cause harm when ingested at or below the acceptable level. A person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.

As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk in continuing to take the recalled APO-Amitriptyline medication since the potential risk of cancer is with long-term exposure (every day for 70 years) to NDMA that exceeds safe levels, which is not what is expected to occur with patients taking this affected medication. As this recall affects only one lot, patients are not expected to be exposed to levels of NDMA that exceed safe levels for an extended period of time. Patients can continue to take their medication as prescribed by their health care provider and do not need to return their medication to their pharmacy.

Health Canada is monitoring the effectiveness of the recall and the company’s implementation of any necessary corrective and preventative actions. Should any additional recalls be deemed necessary, Health Canada will update the table below and inform Canadians.

Affected products

Company Product Strength DIN Lot Expiry Date added
Apotex Inc. APO-Amitriptyline
(Amitriptyline Hydrochloride Tablets USP)
10 mg 02403137 PY1831 12/2023 April 29, 2021
Apotex Inc. APO-Amitriptyline
(Amitriptyline Hydrochloride Tablets USP)
10 mg 02403137 RF0410 05/2024 April 16, 2021

 

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 Apotex Inc. via Stericycle at 1-888-667-1507 if you have questions about the recall.
  • Report any health product-related side effects or complaints to Health Canada.

Background

Health Canada has been working to address the issue of nitrosamine impurities found in certain medications since the summer of 2018. Companies were directed to complete detailed evaluations of their manufacturing processes by the end of March 2021, and are testing products if their reviews identified a potential for nitrosamine formation. As this work progresses, additional products may be identified and recalled as appropriate. Health Canada continues to work closely with international regulatory partners and companies to address the issue and will continue to keep Canadians informed. More information on Health Canada’s work to address nitrosamines in medications is available on Canada.ca.

Media enquiries

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

Public enquiries

(613) 957-2991
1-866 225-0709
hcinfo.infosc@canada.ca