FDA (Drugs) recall action 81887
The FDA (Drugs) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA labs confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) above the interim acceptable daily intake level.
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity NDEA above acceptable daily intake levels.
Aurobindo Pharma USA Inc. is recalling Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.
Aurobindo Pharma USA Inc. is recalling Valsartan tablets because FDA testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA labs found N-nitrosodimethylamine (NDEA) above acceptable levels.
Aurobindo Pharma USA is recalling Amlodipine and Valsartan tablets because FDA testing found NDEA impurity levels above the acceptable daily intake.
Aurobindo Pharma USA Inc. is recalling specific lots of Amlodipine and Valsartan tablets because FDA testing found the impurity NDEA above acceptable levels.