Skip to content

Greenstone

Controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

Back to profile1 entries

  1. 2022

    Pfizer recalls quinapril-containing tablets over nitrosamine impurity

    Recall announced

    Pfizer announced a recall of six lots of Accuretic tablets and two types of quinapril and hydrochlorothiazide tablets because they contained N-nitroso-quinapril above the Acceptable Daily Intake level. The article says Pfizer was not aware of adverse events assessed to be related to the recall.

    Company response

    • Recall — Pfizer

      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.

    Source excerpt

    • 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.