FDA (Drugs) recall action 84218
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: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
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.
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
AuroMedics Pharma LLC is recalling Ranitidine Syrup because N-nitrosodimethylamine (NDMA) has been detected in the product.
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 300 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
AuroMedics Pharma LLC is recalling DG Health Acid Reducer Ranitidine Tablets 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.