FDA (Drugs) recall action 82337
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
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.
Rising Pharmaceuticals is recalling Valsartan Tablets 320 mg due to CGMP deviations and the detection of a trace amount of the impurity N-nitrosodiethylamine (NDEA).
Rising Pharmaceuticals is recalling Valsartan Tablets 40 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.
Rising Pharmaceuticals is recalling Valsartan Tablets 160 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.
Rising Pharmaceuticals is recalling Valsartan Tablets 80 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.