The Recall Desk

FDA (Drugs) recall action 84353

Amneal Pharmaceuticals, Inc. recalled 5 products on 2019-12-18

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
2019-12-18
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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

1–5 of 5

  • SevereFDA (Drugs)··2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-12-18

    Amneal Recalls Ranitidine Syrup Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Syrup Oral Solution because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine 300 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE (RANITIDINE)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE (RANITIDINE)
    Category
    Distribution
    0 states