FDA (Drugs) recall action 83161
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
The agency’s own wording, quoted from the enforcement report.
Golden State Medical Supply Inc. is recalling Losartan Potassium 100 mg tablets because an impurity called NMBA was detected in the active ingredient.
Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.
Golden State Medical Supply is recalling Losartan Potassium 50 mg tablets because a nitrosamine impurity was detected in the active ingredient.
Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.