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Showing 1961–1980 of 2326 results

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

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

Class IIModerate

FDAMar 1, 2019AR, CA, GA +2 more• Legacy Pharmaceutical Packaging LLC

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 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 (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) – 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 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 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 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.

Italian Sub Sandwich (Grand Strand) – Listeria Contamination (2019)

Products may be contaminated with Listeria monocytogenes.

Class IIModerate

FDAJan 4, 2019NC, SC• Grand Strand Sandwich Company,Inc.

Ham & Cheese Sandwich (Grand Strand) – Listeria Risk (2019)

Products may be contaminated with Listeria monocytogenes.

Class IIModerate

FDAJan 4, 2019NC, SC• Grand Strand Sandwich Company,Inc.

Ham & Cheese Croissant (Grand Strand) – Listeria Risk (2019)

Products may be contaminated with Listeria monocytogenes.

Class IIModerate

FDAJan 4, 2019NC, SC• Grand Strand Sandwich Company,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.

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.

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/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.

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.

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