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| Canada: Apotex recalls Apo-Acyclovir tablets due to a nitrosamine impurity (English only) |
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Health Canada announces that Apotex Inc. is recalling 5 lots of Apo-Acyclovir tablets, in 200 mg and 800 mg strengths, due to the presence of a nitrosamine impurity, N-nitrosodimethylamine (NDMA), above the acceptable level. The affected products are:
- Apo-Acyclovir 200 mg Tablet (lot number: RH9368, RH9370)
- Apo-Acyclovir 800 mg Tablet (lot number: RP8516, RP8517, RT8943)
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. People 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.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/apotex-recalls-apo-acyclovir-tablets-due-nitrosamine-impurity
In Hong Kong, Apo-Acyclovir Tab 200mg (HK-43427) and Apo-Acyclovir Tab 800mg (HK-58228) are pharmaceutical products registered by Hind Wing Co Ltd (Hind Wing). Both products are prescription-only medicines.
On 28 Apr 2022, the Department of Health endorsed Hind Wing to recall a total of 4 batches of the following 2 products from the market as a precautionary measure due to the presence of an impurity, N-nitrosodimethylamine (NDMA), in the products:
- Apo-Acyclovir Tab 200mg (HK-43427) (batch number: RH9368, RH9370)
- Apo-Acyclovir Tab 800mg (HK-58228) (batch number: RP8516, RP8517)
A press statement was issued on the same date.
As confirmed with Hind Wing, Apo-Acyclovir Tab 800mg (batch number: RT8943) has not been imported into Hong Kong.
Ends/Friday, Apr 29, 2022
Issued at HKT 15:00
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