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Valsartan & Hydrochlorothiazide (Mylan) – 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 4, 2018Nationwide• Mylan Laboratories Limited, (Nashik FDF)

Amlodipine & Valsartan (Mylan) – 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 4, 2018Nationwide

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Valsartan & Hydrochlorothiazide (Mylan) – NDEA Contamination (2018)

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

Valsartan (Mylan) – NDEA Contamination (2018)

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

Valsartan/Hydrochlorothiazide Tablets (Mylan) – impurity detected (2018)

Valsartan & Hydrochlorothiazide (Mylan) – NDEA Contamination (2018)

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

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

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

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

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

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

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

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

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

Valsartan Tablets (Mylan) – impurity risk (2018)

Valsartan Tablets (Mylan) – impurity risk (2018)

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

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

Valsartan Tablets (Mylan) – impurity risk (2018)