NEW YORK (WFXR) – Pfizer has issued a nationwide recall of some blood pressure medications due to the presence of nitrosamine above the Acceptable Daily Intake (ADI) level.
The recall, announced this week, concerns Accuretic tablets and two generics distributed by Greenstone: quinapril and hydrochlorothiazide, and quinapril HCI/hydrochlorothiazide.
Pfizer will pull six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCI/hydrochlorothiazide tablets.
Health officials say you can also find nitrosamines in water and foods, including dairy products, vegetables and cured and grilled meats. However, exposure to nitrosamines above ADI levels, for long periods of time, can increase the risk of cancer.
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The recalled products are used to help treat hypertension and lower blood pressure to decrease the risk of deadly and non-deadly cardiovascular events, strokes, and myocardial infarctions. Pfizer recommends patients who take this medication should talk to their doctors about alternative treatment options.
The recalled products were distributed from November 2019 to March 2022 throughout the United States and Puerto Rico. Below are the products on the recall list.
- 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 |
Data from Pfizer
- 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 |
Data from Pfizer
Pfizer stated that wholesalers and distributors with any of these products should stop use and distribution, and immediately quarantine the product.
More information about this recall can be found on the Pfizer website.
