Aurobindo Pharma USA Inc.: Amlodipine and Valsartan Tablets USP 10 mg/160 mg,
Recall reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.. Recalled by Aurobindo Pharma USA Inc.. Distribution: Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.. Classification (Class II — potential health risk). Affected lots/NDC/dates: Lot # VFSA17008-A, exp. 10/2019 Lot # VFSA17010-A, exp. 10/2019 Lot # VFSA18002-A, exp. 01/2020 Lot# VFSA18003-A, exp. Return the recalled medication to the pharmacy where you purchased it for a ful
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