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.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0323-2019