Pfizer (NYSE: PFE) Canada is recalling blood pressure therapy, Accuretic due to the presence of a potential cancer-causing impurity called nitrosamine above the acceptable level, the Canadian health regulator said.
The recall applies to all lots of Accuretic in 10/12.5 mg, 20/12.5 mg, and 20/25 mg strengths, Health Canada said.
A prescription drug, Accuretic contains a combination of quinapril hydrochloride and hydrochlorothiazide, both of which lower blood pressure.
There is no immediate risk with the temporary use of the recalled medication, the regulator said, noting that the risk is linked to the long-term exposure to the impurity above the acceptable level. However, it advised the affected patients to seek alternative medications.
“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 to discuss other treatment options,” it said.
The market segment where Canada belongs generated $12.5B revenue for Pfizer in 2021 with a ~210% YoY growth.