Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30

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 # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019

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