News | Hypertension | March 23, 2022

FDA Recalls Quinapril Hydrochloride and Hydrochlorothiazide Tablets by Pfizer

The tablets are being recalled due to N-NitrosoQuinapril content

MedWatch, The FDA Safety Information and Adverse Event Reporting Program, announced today that Pfizer is recalling Accuretic (quinapril hydrochloride/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril HCL and hydrochlorothiazide and quinapril HCl/hydrochlorothiazide) due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake level.

March 23, 2022 — MedWatch, The FDA Safety Information and Adverse Event Reporting Program, announced today that Pfizer is recalling Accuretic (quinapril hydrochloride/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril HCL and hydrochlorothiazide and quinapril HCl/hydrochlorothiazide) due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake level. Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets.

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.

The products being recalled are indicated for the treatment of hypertension. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact the company. Patients currently taking the products should consult with their doctor about alternative treatment options. Healthcare Professionals with questions regarding this recall can contact the company.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

The full expanded list of recalled batches can be found here.

For more information: www.fda.gov

 

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