Teva Pharmaceuticals USA: Amlodipine and Valsartan Tablets 10 mg/320 mg (a)
Recall reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.. Recalled by Teva Pharmaceuticals USA. Distribution: USA Nationwide including Puerto Rico.. Classification (Class II — potential health risk). Affected lots/NDC/dates: NDC 0093-7693-56 & NDC 0093-7693-98 Lot # 26X036, 26X038, 26X039, 26X040, 26X041, 26X042, 26X043, 26X044, 26X045, 26X04. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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