Information Update - Apotex recalls additional Apo-Acyclovir tablets due to a nitrosamine impurity

OTTAWA, ON, July 28, 2022 /CNW/ - Apotex Inc. is recalling four additional 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 or close to 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. 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.

This is an update to a communication on a previous recall. Please see the full advisory for more information, including more on the risk and what patients should do.

Affected Products

Company	Product	DIN	Lot	Expiry
Apotex Inc.	Apo-Acyclovir 200 mg	02207621	RH9369	08/2022
Apotex Inc.	Apo-Acyclovir 200 mg	02207621	TF4466	08/2024
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	TE5062	06/2023
Apotex Inc.	Apo-Acyclovir 800 mg	02207656	TH6119	12/2023

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SOURCE Health Canada

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