Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP  Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536   Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA     NDC 33342-051-10
Reason for recall: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: 20190620
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated