NEW YORK (WWTI) — Pfizer is voluntarily recalling five lots of Accupril tablets that were distributed across the United States over the presence of an organic compound that could increase the risk of cancer.
According to the U.S. Food and Drug Administration, the recall was issued due to the presence of a nitrosamine, known as Nnitroso-quinapril. Recent testing found that the amount of nitrosamines within the Accupril tablets was above the level set for an acceptable daily intake.
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables,” the FDA recall issued Friday explained. “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.”
Accupril is used to treat hypertension, meaning it is intended to lower blood pressure. It can also be used to manage heart failure as adjunctive therapy when added to conventional therapy like diuretics or digitalis.
“Although long-term ingestion of Nnitroso-quinapril may be associated with potential increased cancer risk in humans, there is no immediate risk to patients taking the medication,” according to the recall. If you are currently taking the tablets, you are encouraged to consult with your doctor or health care provider about alternative treatment options.
The recalled product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. The full description of the recalled lots is listed below.
|NDC||Lot Number||Expiration Date||Strength||Configuration/Count|
|0071-0530-23||DR9639||2023 MAR 31||10 mg||1 x 90 count bottle|
|0071-0532-23||DX8682||2023 MAR 31||20 mg||1 x 90 count bottle|
|0071-0532-23||DG1188||2022 MAY 31||20 mg||1 x 90 count bottle|
|0071-0535-23||DX6031||2023 MAR 31||40 mg||1 x 90 count bottle|
|0071-0535-23||CK6260||2022 MAY 31||40 mg||1 x 90 count bottle|
The FDA has asked wholesalers and distributors to stop distribution and quarantine the product immediately. Those who received the affected products should contact Sedgwick at 888-345-0481 for instructions on how to return their product and how to receive reimbursement.