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Showing 1041–1060 of 1310 results

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Amlodipine & Valsartan (Teva) – NDEA Contamination (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine & Valsartan (Teva) – NDEA Contamination (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine, Valsartan, Hydrochlorothiazide (Teva) – impurity risk (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine & Valsartan (Teva) – NDEA Contamination (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine, Valsartan, Hydrochlorothiazide (Teva) – impurity risk (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine & Valsartan (Teva) – NDEA Contamination (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine, Valsartan, Hydrochlorothiazide (Teva) – impurity risk (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine, Valsartan, Hydrochlorothiazide (Teva) – impurity risk (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Valsartan Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Valsartan Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine, Valsartan Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine, Valsartan Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Valsartan Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Valsartan Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Valsartan, Hydrochlorothiazide Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine, Valsartan Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

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

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (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

FDANov 1, 2018OH, PR• Sandoz, Inc

Amlodipine/Valsartan Tablets 5/320mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Amlodipine/Valsartan/HCTZ Tablets 10/160/12.5mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Amlodipine/Valsartan/HCTZ Tablets 5/160/25mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

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