Golden State Medical Supply Inc. recalls Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Recalled May 29, 2019 · FDA recall D-1285-2019 · Golden State Medical Supply
Hazard
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 · FDA Class II
Units
138,213 HDPE Bottles
Sold at
IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
Description
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
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Manufacturer(s)
Golden State Medical Supply Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →