These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API valsartan.
Officials with Mylan Pharmaceuticals today announced that they are expanding a consumer-level voluntary nationwide recall to include all lots of valsartan-containing products within expiry.
The 104 additional lots include 26 lots of amlodipine and valsartan tablets, USP (including the 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg and 10 mg/320 mg strengths), 51 lots of valsartan tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of valsartan and hydrochlorothiazide tablets, USP (80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg strengths).
According to a statement from Mylan, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).
The finished products are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. These batches were distributed in the United States between March 2017 and November 2018.
The expanded recalled batches can be found here.