The Recall Desk

Manufacturer

Prinston Pharmaceutical Inc

16 recalls in our database name Prinston Pharmaceutical Inc as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
14
Most recent
2019-02-06

Of the 16 recalls from Prinston Pharmaceutical Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (88%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • SevereFDA (Drugs)·D-0413-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc is recalling Irbesartan and Hydrochlorothiazide tablets because FDA labs found the impurity NDEA above acceptable levels.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0410-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0409-2019·2019-02-06

    Prinston Recalls Irbesartan Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan 300 mg tablets because FDA testing found N-nitrosodimethylamine (NDEA) levels above the interim acceptable daily intake.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0411-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0412-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable limits.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0973-2018·2018-08-01

    Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc. is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0968-2018·2018-08-01

    Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc. is recalling Valsartan 40 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0974-2018·2018-08-01

    Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0975-2018·2018-08-01

    Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc. is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0972-2018·2018-08-01

    Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0976-2018·2018-08-01

    Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0969-2018·2018-08-01

    Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0970-2018·2018-08-01

    Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0971-2018·2018-08-01

    Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc. is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0209-2018·2018-01-17

    Prinston Recalls Valsartan Tablets Due to Physical Specification Failures

    Prinston Pharmaceutical Inc. is recalling 21,987 bottles of Valsartan 160 mg tablets because customer complaints confirmed the tablets were thicker and heavier than specifications.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1049-2016·2016-06-29

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to Labeling Error

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because an incorrect lot number appears on the case label.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide