FDA (Drugs) recall action 82114
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
The agency’s own wording, quoted from the enforcement report.
Aurobindo Pharma USA is recalling specific lots of Valsartan 80 mg tablets because FDA analysis confirmed trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Aurobindo Pharma USA is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan Tablets USP 320 mg because FDA analysis confirmed the presence of trace amounts of the impurity N-nitrosodiethylamine (NDEA).