Pfizer has issued a recall for a high blood pressure medication distributed under three different names due to an increased risk of cancer, according to the company.
Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level.
Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets.
“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,” Pfizer said in a recall release.
To date, Pfizer said it 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 about alternative treatment options.
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 November 2019 to March 2022.
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
- quinapril and hydrochlorothiazide tablets, 20/25 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/25 mg
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 888-843-0247 (Mon.-Fri. 8:00 am - 5:00 pm ET) to obtain a Business Reply Card (BRC) to initiate the return process.
Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-843-0247 (Mon.-Fri. 8:00 am - 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.