Drugmaker Pfizer issued a voluntary recall on five lots of the prescription blood pressure medication Accupril (Quinapril HCl Tablets) due to the presence of a cancer-causing impurity that was detected to be above the acceptable daily intake level set by the Food and Drug Administration (FDA).
Recent testing found elevated levels of a nitrosamine impurity, Nnitroso-quinapril, in the drug’s 10-, 20- and 40-milligram tablets that were distributed nationwide (including Puerto Rico) to wholesalers and distributors between December 2019 and April 2022.
To date, the company is not aware of reports of anyone being sickened by the recalled drugs.
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In March, Pfizer recalled three other prescription blood pressure medications for elevated levels of a different type of nitrosamine.
Recalled blood pressure medications
Accupril (Quinapril HCl Tablets), 10 mg
- NDC: 0071-0530-23, lot No. DR9639, expiration date 03/31/2023
Accupril (Quinapril HCl Tablets), 20 mg
- NDC: 0071-0532-23, lot No. DX8682, expiration date 03/31/2023
- NDC: 0071-0532-23, lot No. DG1188, expiration date 03/31/2022
Accupril (Quinapril HCl Tablets), 40 mg
- NDC: 0071-0535-23, lot No. DX6031, expiration date 03/31/2023
- NDC: 0071-0535-23, lot No. CK6260, expiration date 03/31/2022
Advice to patients
Patients who are taking Accupril should speak with their health care provider or pharmacy to determine whether they have the recalled product. Those who have the recalled medication should contact Sedgwick, a claims-management company, toll-free at 888-345-0481, Monday through Friday, from 8 a.m. to 5 p.m. ET for instructions on how to return the recalled tablets and receive reimbursement.
Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online or by mail or fax using this downloadable form.
What are nitrosamines?
Long-term ingestion of Nnitroso-quinapril, a type of nitrosamine, may be associated with a potential increased cancer risk in humans. However, there is no immediate risk to patients taking the recalled medications, according to Pfizer.
Nitrosamines are present in water and foods such as cured and grilled meats, dairy products and vegetables. Although everyone is exposed to some level of nitrosamines, the FDA set an internationally recognized acceptable daily intake limit for the impurity. The FDA recommends that drugs containing levels above the acceptable daily intake limit be recalled by the manufacturer as appropriate.
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.
Aaron Kassraie writes about issues important to military veterans and their families for AARP. He also serves as a general assignment reporter. Kassraie previously covered U.S. foreign policy as a correspondent for the Kuwait News Agency’s Washington bureau and worked in news gathering for USA Today and Al Jazeera English.