Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurity

UPDATE (July 28, 2022): Update: Apotex recalls additional Apo-Acyclovir tablets due to a nitrosamine impurity

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. The Affected Products table has been updated with detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians.

Original Advisory (2022-04-28): Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurity

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.