Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
Recall Number: D-1286-2019
Firm: Golden State Medical Supply Inc.
Classification: Class II
Status: Terminated
Report Date: 20190529
Initiation Date: 20190501
Termination Date: 20200225
Reason for Recall
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
Product Description
Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated