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. The recalled tablets were packaged in 90-count bottles and distributed to wholesalers and distributors across the U.S. and Puerto Rico from November 2019 to March 2022 with some expiration dates extending into 2024.
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. A person taking a drug that contains nitrosamines at or below the acceptable daily limit every day for 70 years is not expected to have an increased cancer risk, according to the FDA. There is no immediate risk to patients taking the recalled medications, according to Pfizer.
The recalled products are indicated for the treatment of hypertension. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program. 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 about alternative treatment options.
Patients who are taking Accuretic 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.
Adverse reactions or quality problems experienced with the use of Accuretic may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
The Accuretic recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
If you or a loved one suffered injuries (or worse) as a result of Accuretic or another prescription drug in the United States, you should promptly seek the legal advice of a pharmaceutical claim lawyer (Accuretic lawyer) in your state who may investigate your drug claim for you and represent you in a claim against a pharmaceutical company, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find Accuretic (drug claim lawyers) in your state who may assist you.
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