Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
Reason for recall: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Recall initiated: 20190305
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated