Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient

Defect Levels Handbook

— Mylan N.V. (NASDAQ: MYL) today announced its U.S. established Mylan Pharmaceuticals firm is enlarging its own consumer-level voluntary nationwide recall to include all a lot of Valsartan-containing products inside String. The 104 additional lots comprise 26 plenty of Amlodipine and Valsartan Tablets, USP (such as the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 plenty of Valsartan Tablets, USP (such as 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 many Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).

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