Glenmark Pharmaceuticals’ subsidiary -- Glenmark Pharmaceuticals Inc., USA (Glenmark) is voluntarily recalling all unexpired lots of its ranitidine tablets, used to treat ulcers of the stomach and intestines, from the US market. The tablets are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the United States Food and Drug Administration (USFDA). The affected ranitidine tablets were distributed directly to wholesalers, distributors, retailers and repackagers nationwide.
The company's Ranitidine tablets 150 mg and 300 mg are manufactured at two approved manufacturing facilities. Of the 928 recalled lots of ranitidine tablets, USP, 16 lots were manufactured by Glenmark Pharmaceuticals, Goa, and 912 lots were manufactured by Strides Pharma Science, Puducherry.
Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).
