GlaxoSmithkline Pharmaceuticals has recalled ranitidine hydrochloride tablets produced in India using API sourced from Saraca Laboratories following detection of genotoxic nitrosamine NDMA by authorities.
The company has also decided to suspend release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations.
GlaxoSmithKline Pharmaceuticals (GSK Rx India) is one of the oldest pharmaceuticals company. The GSK India product portfolio includes prescription medicines and vaccines.
