Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated

Recall Number: D-1285-2019

Firm: Golden State Medical Supply Inc.

Classification: Class II

Status: Terminated

Report Date: 20190529

Initiation Date: 20190501

Termination Date: 20200225

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated