Alert date March 24, 2022

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Pfizer Voluntary Nationwide Recall of Lots of ACCURETIC™ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide Tablets, and quinapril HCl/hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril Content

Pfizer Inc. is recalling a blood pressure drug because of elevated levels of a potential cancer-causing impurity.

The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from November 2019 to March 2022.

The company warned consumers on Monday of several tainted lots of Accuretic and two other versions of the drug — quinapril and hydrochlorothiazide tablets – because of the presence of a nitrosamine above the Acceptable Daily Intake 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,” according to the Food and Drug Administration.

It adds: “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”

The medications are prescribed for the treatment of hypertension to reduce the risk of cardiovascular events, primarily strokes and myocardial infarctions

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
NDC Lot Number Expiration Date Strength Configuration/Count
0071-3112-23 FG5379 08/2024 10/12.5 mg 1 x 90 count bottle
0071-0222-23 EA6686 04/2022 10/12.5 mg 1 x 90 count bottle
0071-5212-23 FG5381 08/2024 20/12.5 mg 1 x 90 count bottle
0071-0220-23 EA6665 04/2022 20/12.5 mg 1 x 90 count bottle
0071-0220-23 CN0640 04/2022 20/12.5 mg 1 x 90 count bottle
0071-0223-23 ET6974 02/2023 20/25 mg 1 x 90 count bottle

quinapril and hydrochlorothiazide tablets, 20/25 mg
quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
quinapril HCl/hydrochlorothiazide tablets, 20/25 mg
NDC Lot Number Expiration Date Strength Configuration/Count
59762-5225-9 FE3714 02/2023 20/25 mg 1 x 90 count bottle
59762-0220-1 DN6931 03/2023 20/12.5 mg 1 x 90 count bottle
59762-0220-1 ED3904 03/2023 20/12.5 mg 1 x 90 count bottle
59762-0220-1 ED3905 03/2023 20/12.5 mg 1 x 90 count bottle
59762-0223-1 DP3414 02/2023 20/25 mg 1 x 90 count bottle