The Recall Desk

FDA (Drugs) recall action 82314

AVKARE Inc. recalled 3 products on 2019-03-27

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2019-03-27
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified

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

1–3 of 3

  • SevereFDA (Drugs)··2019-03-27

    AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
    Category
    Distribution
    0 states