Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 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: GS014054 exp 06/2019, GS016338 exp 12/2019, GS016341 exp 01/2020, GS016342 exp 01/2020, GS016343 exp 01/2020, GS016344 exp 01/2020, GS016345 exp 01/2020, GS016539 exp 01/2020, GS016969 exp 01/2020, GS016973 exp 01/2020, GS017337 exp 01/2020, GS018524 exp 02/2020

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