FDA (Drugs) recall action 84516
The FDA (Drugs) publishes a recall like this one as 6 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 6 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.
Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 150 mg because testing detected the presence of the NDMA impurity.
Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because the FDA detected the NDMA impurity in the product.
Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 150 mg because the product contains the NDMA impurity.
Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because the FDA detected the NDMA impurity in the product.
Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because of the presence of the NDMA impurity.
Glenmark Pharmaceuticals is recalling 217,956 bottles of Ranitidine Tablets USP 150 mg nationwide because the product contains the NDMA impurity.