Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.

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.

Code information: Lot # VUSD17008-A, exp. date 07/2019 Lot # VUSD17009-A, exp. date 09/2019

Distribution pattern: Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.