Pfizer is voluntarily recalling five lots of Accupril (Quinapril HCI) due to unacceptable levels of a nitrosamine, N-nitroso-quinapril, a potential carcinogen, the company announced.
The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.
Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.
To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall and the company believes the benefit/risk profile 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," the company said April 22 in a news release.
Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.
The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.
National drug codes (NDC), lot numbers and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.
Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.
Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.
Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.
Lead Image: US Food & Drug Administration
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Cite this: Pfizer Recalls More Quinapril Due to Potential Carcinogen - Medscape - Apr 26, 2022.