FDA (Drugs) recall action 84353
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 N-nitrosodimethylamine (NDMA) found in API
The agency’s own wording, quoted from the enforcement report.
Amneal Pharmaceuticals is recalling Ranitidine 300 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
Amneal Pharmaceuticals is recalling Ranitidine Syrup Oral Solution because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
Amneal Pharmaceuticals is recalling Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).