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Showing 1241–1260 of 1571 results

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Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Class IIModerate

FDAFeb 28, 2019Nationwide• Camber Pharmaceuticals Inc

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Class IIModerate

FDAFeb 28, 2019Nationwide• Camber Pharmaceuticals 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• Torrent Pharma Inc.

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) – 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) – 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) – 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.

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

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Tablets (Aurobindo) – NDEA contamination (2018)

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Tablets (Aurobindo) – NDEA contamination (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

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