Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30

Reason: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Code information: 470170038A, exp. date 10/31/2019 470180010A, exp. date 02/29/2019 470180012A, exp. date 03/31/2020

Distribution pattern: Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.