FDA (Drugs) recall action 81613
The FDA (Drugs) publishes a recall like this one as 8 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 8 pages.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
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.
Mylan Pharmaceuticals is recalling Valsartan tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.
Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).
Mylan Pharmaceuticals is recalling Valsartan 40 mg tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).
Mylan Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).
Mylan Pharmaceuticals is recalling Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.
Mylan Pharmaceuticals is recalling specific lots of Valsartan 320 mg tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).