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Drug Safety Alerts
Accupril® Tablet Consumer-Level Recall
4/22/2022
On April 22, 2022, Pfizer issued a patient-level recall of Accupril® (quinapril HCl) tablets distributed by Pfizer. 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 five lots of Accupril® tablets.
A complete list of the affected products and lot numbers can be found here.
This could be a health hazard or safety risk to plan members who may be 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.
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 30 years of marketing authorization and through a robust clinical program and that, to date, Pfizer is not aware of any reports of adverse events that have been linked to this recall. Pfizer believes the benefit/risk profile of the products remains favorable 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 about this recall, please call Pfizer Medical Information at 1-800-438-1985, Monday through Friday, 8:00 am to 9:00 pm (EST) or visit www.pfizermedinfo.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.