The Recall Desk

FDA (Drugs) recall action 81838

Torrent Pharma Inc. recalled 5 products on 2019-02-27

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
2019-02-27
Critical
0
Units
229,896

Why these products were recalled

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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.

States named across these recalls

1–5 of 5

  • SevereFDA (Drugs)··2019-02-27

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-02-27

    Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 100 mg, because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above the interim acceptable daily intake level.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-02-27

    Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-02-27

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA labs found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-02-27

    Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
    Category
    Distribution
    1 state