Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15

Recall Number: D-1044-2019

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 Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15