FDA-Drug2019-05-29Class II
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Golden State Medical Supply Inc.
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
Sold states
IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
Affected count
138,213 HDPE Bottles
Manufactured in
5187 Camino Ruiz, N/A, Camarillo, CA, United States
Products
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1285-2019Don't want to check this manually?
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