Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated

Reason: 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

Code information: GS015172 exp 06/2019 GS017634 02/2020, GS017653 exp 02/2020, GS017980 exp 02/2020, GS017276 exp 02/2020, GS017045 exp 02/2020,GS016726 exp 02/2020,

Distribution pattern: IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.