Pfizer Canada ULC is recalling all lots of the prescription drug Accupril in 10 mg, 20 mg and 40 mg strengths due to the presence of a nitrosamine impurity above the acceptable level.
OTTAWA, ON, April 21, 2022 /CNW/ - Pfizer Canada ULC is recalling all lots of the prescription drug Accupril (quinapril hydrochloride) in 10 mg, 20 mg and 40 mg strengths due to the presence of a nitrosamine impurity (N-nitroso-quinapril) above the acceptable level.
Long-term exposure to N-nitroso-quinapril at a level above what is considered acceptable may increase the risk of cancer. 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.
Health Canada maintains a list of recalled quinapril drugs affected by this issue. Please see the full advisory for more information, including more on the risk and what patients should do.
Affected Products
|
Product |
DIN |
Lot |
Expiry |
|
Accupril 10mg |
01947672 |
DY3042 |
2023-03-31 |
|
Accupril 10mg |
01947672 |
CK5285 |
2022-05-31 |
|
Accupril 20mg |
01947680 |
DT9592 |
2023-03-31 |
|
Accupril 20mg |
01947680 |
CK6258 |
2022-05-31 |
|
Accupril 20mg |
01947680 |
CK6259 |
2022-05-31 |
|
Accupril 40mg |
01947699 |
DT9591 |
2023-03-31 |
|
Accupril 40mg |
01947699 |
CM2828 |
2022-05-31 |
|
Accupril 40mg |
01947699 |
CM2829 |
2022-05-31 |
Également disponible en français
SOURCE Health Canada
