Search U.S. Product Recalls Database

Showing 1981–2000 of 2326 results

Sort:

Amlodipine/Valsartan Tablets (Aurobindo) – NDEA impurity (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 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

Stay Informed

Search Product Recalls

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

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

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

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

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

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

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

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

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

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

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

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

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

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

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

Valsartan (Mylan) – NDEA Contamination (2018)

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

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

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

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