Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient

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Mylan N.V. (NASDAQ: MYL) today announced its U.S. established Mylan Pharmaceuticals firm is running a voluntary nationwide recall to the customer level of pick a lot of Valsartan-containing goods, such as six tons of Amlodipine and Valsartan Tablets, USP (such as the 5mg/160milligrams, 10milligrams /160milligrams, also 10mg/320mg strengths), seven tons of Valsartan Tablets, USP (such as 40 mg, 80 mg, 160 mg, also 320 mg strengths), and 2 tons of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25milligrams potency. These goods are being recalled because of found trace amounts of an impurity, N-nitrosodiethylamine (NDEA) included at the API Valsartan, USP, made by Mylan Laboratories Limited. NDEA is a chemical that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen based on the International Agency for Research on Cancer (IARC).

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