Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.
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.i
Accupril is indicated for the treatment of hypertension, to lower blood pressure. Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years. 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. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.
The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.
Accupril® (Quinapril HCl Tablets), 10 mg
Accupril® (Quinapril HCl Tablets), 20 mg
Accupril® (Quinapril HCl Tablets), 40 mg
Lot Number |
Expiration Date |
Strength |
Configuration/Count |
|
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 |
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 |
CK6260 |
2022 MAY 31 |
40 mg |
1 x 90 count bottle |
Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.
Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.
If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the affected product and promptly contact Sedgwick at 888-345-0481 (Mon.-Fri.8:00 am - 5:00 pm ET) to obtain a Business Reply Form (BRF) to initiate the return process.
