Product: Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg,  1000-count bottles, Rx Only, Finished Drug Product Manufactured by:  Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ   08540, NDC 0781-5207-10.
Reason for recall: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above  the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated: 20181101
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated