Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for:  Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by:  Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India.  NDC 33342-0052-10
Reason for recall: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Recall initiated: 20190221
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated