Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15

Recall Number: D-1045-2019

Firm: AVKARE Inc.

Classification: Class II

Status: Terminated

Report Date: 20190327

Initiation Date: 20190305

Termination Date: 20201207

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15