Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90

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

Code information: 471170019A, exp. date 10/31/2019 471180006A, exp. date 03/31/2020 471180007A, exp. date 03/31/2020 471180016A, exp. date 05/31/2020

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