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Pfizer Recalls Blood Pressure Drug Accuretic in UK Due to Nitrosamine Risk

Pfizer Recalls Blood Pressure Drug Accuretic in UK Due to Nitrosamine Risk

Quinapril hydrochloride

Pfizer has recalled a single batch of its blood pressure drug, Accuretic (quinapril HCl/hydrochlorothiazide), in the UK following the detection of a nitrosamine contaminant, N-nitroso-quinapril, at levels above the acceptable limit.

The batch of concern, numbered DD4842, was for quinapril HCl 10 mg/ hydrochlorothiazide 12.5 mg film-coated tablets distributed in April 2020.



N-nitroso-quinapril

Consumption of nitrosamine at amounts above acceptable levels long-term could lead to an increased risk of cancer.

The recall will affect Accuretic supply at the wholesaler and pharmacy levels, the company said.

Accuretic is a prescription medicine used to treat the symptoms of High Blood Pressure (Hypertension). Accuretic may be used alone or with other medications.

Accuretic belongs to a class of drugs called ACEI/Diuretic Combos; ACEI/HCTZ Combos.

It is not known if Accuretic is safe and effective in children younger than 18 years of age.


April 4, 2022

https://www.fdanews.com/

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