The Recall Desk

FDA (Drugs) recall action 89864

Pfizer Inc. recalled 8 products on 2022-04-13

The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products
8
Announced
2022-04-13
Critical
0
Units
26,691

Why these products were recalled

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

  • ModerateFDA (Drugs)··2022-04-13

    Quinapril and Hydrochlorothiazide Tablets Recalled for Elevated Chemical Impurity

    Pfizer is recalling quinapril and hydrochlorothiazide tablets (20 mg/25 mg) nationwide due to elevated chemical impurities exceeding acceptable daily intake limits. No illnesses have been reported.

    Product
    quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-04-13

    Pfizer Recalls Blood Pressure Tablets Due to Manufacturing Defects

    Pfizer is recalling quinapril HCl/hydrochlorothiazide tablets due to manufacturing defects that allowed N-nitroso impurities to exceed acceptable daily intake limits. Patients taking affected lots should contact their pharmacy.

    Product
    quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-04-13

    Pfizer recalls Accuretic blood pressure tablets for impurities exceeding acceptable limits

    Pfizer is recalling 53 bottles of Accuretic blood pressure tablets nationwide due to manufacturing impurities that exceed FDA acceptable daily intake limits. The affected lot is FG5379, expiring August 2024.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-04-13

    Pfizer Accuretic Blood Pressure Tablets Recalled for Chemical Impurity

    Pfizer is recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets nationwide due to unacceptable levels of N-nitroso chemical impurities from manufacturing deviations. The affected lot includes 160 bottles.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-04-13

    Accuretic Blood Pressure Tablets Recalled for Excess Chemical Impurity

    Pfizer is recalling Accuretic blood pressure tablets due to manufacturing deviations that resulted in N-nitroso chemical impurities exceeding safe intake limits. Patients should contact their pharmacist or physician.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-04-13

    Accuretic tablets recalled for N-nitroso impurities exceeding safe limits

    Pfizer is recalling 195 bottles of Accuretic blood pressure tablets nationwide due to N-nitroso impurities exceeding acceptable daily intake limits. No illnesses have been reported.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-04-13

    Pfizer Recalls Quinapril/Hydrochlorothiazide Tablets for N-Nitroso Impurities

    Pfizer is recalling 1,104 bottles of quinapril/hydrochlorothiazide tablets due to nitrosamine impurities above acceptable limits. The affected lot (DP3414) was distributed nationwide.

    Product
    quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-04-13

    Accuretic Tablets Recalled Due to Excess N-Nitroso Impurity

    Pfizer is recalling Accuretic (quinapril/hydrochlorothiazide) tablets nationwide due to N-nitroso impurities exceeding acceptable daily intake limits. The impurity resulted from a manufacturing deviation.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.
    Category
    Distribution
    0 states