FDA (Drugs) recall action 85306
The FDA (Drugs) publishes a recall like this one as 3 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 3 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.
Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets 100 mg because an impurity called NMBA was detected in the active ingredient.
Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets because an impurity was detected in the active pharmaceutical ingredient.
Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets 50 mg because an impurity, NMBA, was detected in the active pharmaceutical ingredient.