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Losartan Hydrochlorothiazide Tablets (Torrent) – Impurity Risk (2019)

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

Class IIModerate

FDAFeb 28, 2019Nationwide• Torrent Pharma Inc.

Losartan Potassium Tablets (Torrent Pharma) – NMBA Impurity (2019)

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

Class IIModerate

FDAFeb 28, 2019Nationwide

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Losartan Hydrochlorothiazide Tablets (Torrent) – Impurity Risk (2019)

Losartan Potassium Tablets (Torrent Pharma) – NMBA Impurity (2019)

Losartan Potassium Tablets (Torrent) – Impurity Risk (2019)

Losartan Potassium Tablets (Torrent) – Impurity Risk (2019)

Losartan Potassium Tablets (Torrent) – Impurity Risk (2019)

Valsartan/HCTZ Tablets (Aurobindo) – NDEA impurity (2018)

Amlodipine Valsartan Tablets (Aurobindo) – NDEA Impurity (2018)

Valsartan Tablets (Aurobindo) – NDEA trace amounts (2018)

Amlodipine/Valsartan Tablets (Aurobindo) – NDEA impurity (2018)

Amlodipine/Valsartan Tablets (Aurobindo) – NDEA risk (2018)

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

Valsartan Tablets (Aurobindo) – NDEA contamination (2018)

Valsartan Tablets (Aurobindo) – NDEA contamination (2018)

Amlodipine Valsartan Tablets (Aurobindo) – NDEA Impurity (2018)

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

Valsartan/HCTZ Tablets (Aurobindo) – NDEA contamination (2018)

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

Losartan Potassium Tablets (Torrent) – NDEA Impurity (2018)