Pfizer recalls some lots of BP drug Accupril over presence of nitrosamine

Published On 2022-04-23 10:40 GMT   |   Update On 2022-04-25 05:36 GMT
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New York: Pfizer has announced the voluntary recall of five 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.
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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 company stated.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the table below. 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

NDC

Lot Number

Expiration Date

Strength

Configuration/Count

0071-0532-23

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

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

"Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product," the company added.

Read also: Pfizer COVID drug Paxlovid strongly recommended by WHO

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