Aurobindo Pharma USA Inc.: Valsartan Tablets USP 80 mg, 90 count bottles
Recall reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.. Recalled by Aurobindo Pharma USA Inc.. Distribution: Product was distributed to major distribution chains throughout the United States.. Classification (Class II — potential health risk). Affected lots/NDC/dates: Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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