FDA (Drugs) recall action 84147
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
CGMP Deviations: Presence of NDMA impurity detected in product.
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.
Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because of the presence of the NDMA impurity. The recall covers 6,660 bottles distributed nationwide.
Novitium Pharma LLC is recalling 2,718 bottles of Ranitidine Capsules 150 mg because the product contains the NDMA impurity.
Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because the product was found to contain the NDMA impurity.
Novitium Pharma LLC is recalling 19,560 bottles of Ranitidine Capsules 150 mg nationwide because the product contains the NDMA impurity.