Aurobindo Pharma USA Inc.: Valsartan Tablets USP 160 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: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 4. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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