Aurobindo Pharma USA Inc.: Valsartan tablets USP 320 mg, 90-count bottles
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 # VUSD17008-A, exp. date 07/2019 Lot # VUSD17009-A, exp. date 09/2019. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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