UPDATE: April 21, 2022 – Pfizer recalls Accupril blood pressure tablets due to a nitrosamine impurity 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. Accupril, like the previously recalled Accuretic drug, is used to treat high blood pressure. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. Original Advisory: March 3, 2022 – Pfizer recalls Accuretic blood pressure tablets due to a nitrosamine impurity Pfizer Canada ULC is recalling all lots of Accuretic (quinapril hydrochloride and hydrochlorothiazide) medication in 10/12.5 mg, 20/12.5 mg and 20/25 mg strengths due to the presence of a nitrosamine impurity ( N -nitroso-quinapril) above the acceptable level. Accuretic is a prescription drug used to treat high blood pressure. It contains a combination of quinapril hydrochloride and hydrochlorothiazide, which both lower blood pressure. Long-term exposure to N -nitroso-quinapril at 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. As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk to patients temporarily taking this medication since the potential risk of cancer is with long-term (every day for 70 years) exposure to nitrosamine impurities that exceeds safe levels, which is not what is expected to occur with patients taking the affected medication for a short period of time. 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.
RecallTracker