Apotex Inc. is recalling four additional lots of Apo-Acyclovir tablets, in 200 mg and 800 mg strengths, due to the presence of a nitrosamine impurity above or close to the acceptable level.
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
