Granules India says ‘voluntarily’ recalling ranitidine tabs

Drug firm Granules India has said it is ‘voluntarily’ recalling ranitidine tablets used to treat ulcers of the stomach and intestines. “Ranitidine is being recalled by various producers from the US market as they contain unacceptable levels of N — nitrosodimethylamine (NDMA). Granules India is recalling this product voluntarily,” the drug firm said in a filing to BSE.

The company further said, “The voluntary ongoing recall is a class II recall.” It also said it has received multiple queries on the news item for recall of ranitidine by the drug firm. “The quantities being referred in various news websites at this point of time is the last one year sale from Granules India to Granules USA, subsidiary of the company,” it said. The company is in the process of recall from channel partners and the exact quantities are being estimated, the company said adding that it believes this will not have any material impact on its financials.