Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.

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: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617

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