The Recall Desk

FDA (Drugs) recall action 88856

Lupin Pharmaceuticals Inc. recalled 5 products on 2021-11-10

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2021-11-10
Critical
0
Units
466,164

Why these products were recalled

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

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.

1–5 of 5

  • SevereFDA (Drugs)··2021-11-10

    Irbesartan and Hydrochlorothiazide Tablets Recalled for Impurity Contamination

    Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient, which resulted from CGMP deviations.

    Product
    Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-11-10

    Irbesartan 300 mg tablets recalled for impurity in active ingredient

    Lupin Pharmaceuticals is recalling Irbesartan 300 mg tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects approximately 119,544 bottles distributed nationally.

    Product
    IRBESARTAN (IRBESARTAN)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-11-10

    Irbesartan Tablets Recalled for Impurity in Active Ingredient

    Lupin Pharmaceuticals is recalling Irbesartan tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects 30-count and 90-count bottles distributed nationwide.

    Product
    IRBESARTAN (IRBESARTAN)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2021-11-10

    Lupin Irbesartan Tablets Recalled for Impurity Contamination

    Lupin Pharmaceuticals is recalling Irbesartan 75 mg tablets due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient. The recall affects 51,144 bottles distributed nationwide.

    Product
    IRBESARTAN (IRBESARTAN)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-11-10

    Lupin Pharmaceuticals Irbesartan/Hydrochlorothiazide Tablets Recalled for Impurity

    Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets USP (300/12.5 mg) in 30-count and 90-count bottles due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient.

    Product
    Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
    Category
    Distribution
    0 states