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OTTAWA, ON, April 28, 2022 /PRNewswire/ –
Summary
Products: Apo-Acyclovir (acyclovir) tablets of two hundred mg and 800 mg
Problem: Some batches are removed due to the presence of a nitrosamine impurity above the appropriate level.
What to do: Continue to take your medicine unless your health care provider has asked you to stop taking it. You do not want to take your medicine back to the pharmacy. Not treating your condition may pose a greater risk to your fitness.
Apotex Inc. is recalling certain batches of apo-acyclovir (acyclovir) tablets, in doses of two hundred mg and 800 mg, due to the presence of a nitrosamine impurity (N-nitrosodimethylamine [NDMA]) above the appropriate level.
Apo-acyclovir is a prescription antiviral medication used to treat shingles and to treat recurrence of genital herpes.
NDMA is classified as a probable human carcinogen. This means that long-term exposure to a point above what is appropriate can increase the threat of cancer. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and salted meats, dairy and vegetable products), drinking water, and air pollution. This impurity is not expected to cause harm when ingested at or below the appropriate point. The day for 70 years is not expected to have an increasing threat of cancer.
Patients can continue to take their medications as prescribed through their physical care provider and do not want to return their medications to their pharmacy, but contact their physical care provider if they have taken the recalled product and are involved in their physical condition.
There is no immediate threat when proceeding to take the recalled drug, as the greatest threat of cancer comes from long-term exposure to nitrosamine impurity above the appropriate level.
Health Canada is tracking the effectiveness of the company’s recall and implementation of all corrective and preventive measures. If more withdrawals are considered, Array Health Canada will update the table and let Canadians know.
Products in question
Company
Product
DIN
Drawn
Expiration
apotex inc.
Apo-Acyclovir two hundred mg
02207621
RH9368
08/2022
apotex inc.
Apo-Acyclovir two hundred 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
Que haces
Continue to take your medicine unless your physical care provider has asked you to stop taking it. You do not want to take your medicine back to the pharmacy. Not treating your condition may pose a greater risk to your fitness.
Talk to your physical care provider if you are taking a recalled product and are concerned about your physical condition.
If you have any questions about the retreat, please contact Apotex Inc. at 1-888-628-0732 or email apotex4315@sedgwick. com.
Report any effects or court cases similar to a fitness product to Health Canada.
Background
Health Canada has been running to address nitrosamine impurities in some drugs since the summer of 2018. Companies were asked to carry out detailed tests of their production processes and check the products if their reviews were aware of the possibility of nitrosamine formation. it can be known and withdrawn, as appropriate. Health Canada continues to work heavily with foreign regulatory partners and companies to address the factor and will continue to keep Canadians informed. in Canada. ca.
Associated links
Nitrosamine impurities in drugs: overview
Also available in French
SOURCE Health Canada
View Content: http://www. newswire. ca/en/releases/archive/April2022/28/c7755. html