Teva Pharmaceuticals USA: Amlodipine and Valsartan Tablets 5 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 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, 25X037. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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