Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.

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.

Code information: Lot Numbers:3064084, 3069629, 3073148, 3073149,3076093, 3077772

Distribution pattern: Product was distributed throughout the United States to several major distributors, including Puerto Rico.