The Recall Desk

FDA (Drugs) recall action 82585

Torrent Pharma Inc. recalled 6 products on 2019-04-17

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2019-04-17
Critical
0
Units
1,078,056

Why these products were recalled

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

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

1–6 of 6

  • SevereFDA (Drugs)··2019-04-17

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen…
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-04-17

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For…
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-04-17

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For…
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-04-17

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 25 mg, because FDA labs found an impurity above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking…
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-04-17

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 100 mg, because FDA testing found an impurity above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking…
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2019-04-17

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing found an impurity above acceptable levels.

    Product
    LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150…
    Category
    Distribution
    1 state