NEW YORK, NY, APRIL 22,2022.
Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed to patients (consumers/users) due to the presence of a nitrosamine, N-nitroso-quinapril, found in recent testing above the Acceptable Daily Intake (ADI).
Nitrosamines are commonly found in water and foods such as cured and grilled meats, dairy products, and vegetables. Nitrosamines are present in everyone's environment in some form. If people are exposed to these impurities at levels above acceptable levels for an extended period, they may increase their risk of cancer. Accupril is used to treat hypertension by lowering blood pressure. Accupril is also indicated as adjunctive therapy in the treatment of heart failure when combined with conventional therapy such as diuretics. Accupril has a proven safety record dating back over 30 years. Pfizer is not aware of any reports of adverse events that have been linked to this recall as of yet. Based on current data, Pfizer believes the benefit/risk profile of the products remains positive. Although long-term ingestion of N-nitroso-quinapril may be associated with increased cancer risk in humans, patients taking this medication face no immediate danger. Patients who are currently using the products should talk to their doctor or health care provider about alternative treatment options.
From December 2019 to April 2022, the product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico.
Pfizer prioritizes patient safety and product quality at every stage of the manufacturing and supply chain processes. Pfizer has written to direct consignees to arrange for the return of any recalled product.
Wholesalers and distributors who have an existing inventory of the lots listed in the table above should immediately cease use and distribution and quarantine the product.
Please notify any accounts or additional locations that may have received the recalled product from you if you have distributed it further. Please conduct a sub-recall for those accounts and distribute this recall information as soon as possible. Please request that they immediately stop selling the affected product and contact Sedgwick at 888-345-0481 (Mon-Fri 8:00 a.m. - 5:00 p.m. ET) to obtain a Business Reply. Please check your stock immediately against the table above if you received free products through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP). If you have any of the affected product lots in your inventory, please follow the steps outlined above to return them to Sedgwick. Furthermore, if you are aware of any patients to whom you dispensed the affected lots who may still have the product in their possession, please ask them to return it to you and then follow the instructions above for returning the product to Sedgwick. Please call 833-203-2776 to request a replacement product for any Pfizer PAP or Pfizer IPAP product you return (Mon.-Fri. 8 am-6 pm ET).
Patients who use this product should check with their healthcare provider or pharmacy to see if they have the affected product. Patients who have the affected product should contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 a.m. - 5:00 p.m. ET) for instructions on how to return it and receive reimbursement for the cost.
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