Advisory - Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurity

OTTAWA, ON, April 28, 2022 /CNW/ - 

Summary

• Products: Apo-Acyclovir (acyclovir) 200 mg and 800 mg tablets
• Issue: Certain lots are being recalled due to the presence of a nitrosamine impurity above the acceptable level.
• What to do: Continue taking your medication unless you have been advised to stop by your health care provider. You do not need to return your medication to your pharmacy. Not treating your condition may pose a greater health risk.

Issue

Apotex Inc. is recalling certain lots of Apo-Acyclovir (acyclovir) tablets, in 200 mg and 800 mg strengths, due to the presence of a nitrosamine impurity (N-nitrosodimethylamine [NDMA]) above the acceptable level.

Apo-Acyclovir is a prescription antiviral drug used to treat shingles, and to treat or reduce the recurrence of genital herpes.

NDMA is classified as a probable human carcinogen. This means that long-term exposure to a level above what is considered acceptable 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. This impurity is not expected to cause harm when ingested at or below the acceptable level. A person taking a drug that contains this impurity at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.

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, but they should contact their health care provider if they have taken the recalled product and are concerned about their health.

There is no immediate risk in continuing to take the recalled medication, since the increased risk of cancer typically involves long-term exposure to the nitrosamine impurity above the acceptable level.

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.

Affected products

Company	Product	DIN	Lot	Expiry
Apotex Inc.	Apo-Acyclovir 200 mg	02207621	RH9368	08/2022
Apotex Inc.	Apo-Acyclovir 200 mg	02207621	RH9370	08/2022
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	RP8516	07/2022
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	RP8517	07/2022
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	RT8943	07/2022

What you should do

• Continue taking your medication unless you have been advised to stop by your health care provider. You do not need to return your medication to your pharmacy. Not treating your condition may pose a greater health risk.
• Talk to your health care provider if you are taking a recalled product and are concerned about your health.
• If you have questions about the recall, contact Apotex Inc. at 1-888-628-0732 or by email at [email protected].
• 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 and to test 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.

Related links

• Nitrosamine impurities in medications: Overview

Également disponible en français

SOURCE Health Canada

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]