Drug Safety Alerts

Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets Patient-Level Recall

3/21/2022

On March 21, 2022, Pfizer issued a patient-level recall of Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide). This recall was issued due to the presence of a specific nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level. Pfizer is recalling six lots of Accuretic™ tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

A list of the affected products and lot numbers is provided at the end of this here.

These products are indicated for the treatment of hypertension. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. According to Pfizer, the products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program and, to date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long- term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication.

Pfizer recommends that patients currently taking the products consult with their doctor about alternative treatment options.

CVS Caremark Response: Because of this action, CVS Caremark is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking these products to contact their prescriber.

For more information, please call Pfizer Medical Information at 1-800-438-1985, Monday through Friday, 8:00 am to 9:00 pm (ET) or visit www.pfizer.com.

You may also call the U.S. Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.