FDA (Drugs) recall action 82281
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; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Camber Pharmaceuticals is recalling Losartan Potassium tablets because trace amounts of the nitrosamine NMBA were detected in the active ingredient.
Camber Pharmaceuticals is recalling Losartan Potassium tablets because trace amounts of the impurity NMBA were detected in the active ingredient.
Camber Pharmaceuticals is recalling Losartan Potassium tablets because trace amounts of the nitrosamine NMBA were detected in the active ingredient.