Public advisory

Amitriptyline antidepressant drugs recalled because of a nitrosamine impurity

Last updated

Summary

Product
Elavil (amitriptyline) 10 mg tablets and APO-Amitriptyline 10 mg tablets
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

Company Product Strength DIN Lot Expiry Date added
AA Pharma Inc. Elavil
(Amitriptyline Hydrochloride Tablets USP)
10 mg 00335053 PY1829 12/2023 2022-01-26
AA Pharma Inc. Elavil
(Amitriptyline Hydrochloride Tablets USP)
10 mg 00335053 PY1830 12/2023 2022-01-26
Apotex Inc. APO-Amitriptyline
(Amitriptyline Hydrochloride Tablets USP)
10 mg 02403137 PY1832 12/2023 2022-01-26
Apotex Inc. APO-Amitriptyline
(Amitriptyline Hydrochloride Tablets USP)
10 mg 02403137 PY1831 12/2023 2021-04-29
Apotex Inc. APO-Amitriptyline
(Amitriptyline Hydrochloride Tablets USP)
10 mg 02403137 RF0410 05/2024 2021-04-16

Issue

UPDATE: January 26, 2022

Certain lots of Elavil (amitriptyline) and APO-Amitriptyline recalled due to a nitrosamine impurity

AA Pharma Inc. is recalling two lots of Elavil (amitriptyline) (lots PY1829 and PY1830) and Apotex Inc. is recalling one additional lot of APO-Amitriptyline (lot PY1832) 10 mg tablets due to the presence of NDMA, a nitrosamine impurity, above the acceptable limit. See the Affected Products table for more information on the recalled lots. Patients can continue taking their amitriptyline drugs, as the risks from not having adequate treatment outweigh possible effects of exposure to the levels of NDMA seen in the recalled products. Patients do not need to return their medication to the pharmacy (see further information below, under “What you should do”).

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

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 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 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 and inform Canadians.

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 1-888-266-7914, or by email at apotex5117@sedgwick.com
    • AA Pharma at 1-905-669-1565
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

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.

Details
Original published date: 2021-10-28
Alert / recall type
Public advisory
Category
Health product - Drugs
Published by
Health Canada
Audience
General public
Identification number
RA-62345
Media and public enquiries

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