FDA (Drugs) recall action 83151
The FDA (Drugs) publishes a recall like this one as 5 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 5 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.
Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active ingredient.
Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active pharmaceutical ingredient.
Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active ingredient.
Macleods Pharma USA Inc. is recalling Losartan Potassium tablets because an impurity was detected in the active ingredient.
Macleods Pharma USA Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.