GSK decides to recall antacid Zinetac over safety concern
GlaxoSmithKline Pharmaceuticals Ltd on Wednesday announced recall of ranitidine hydrochloride tablets produced in India using API sourced from Saraca Laboratories Ltd 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 said in a regulatory.
GSK Pharma said it has been contacted by regulatory authorities regarding detection of genotoxic nitrosamine NDMA in ranitidine products.
Subsequently, Saraca Laboratories Ltd were notified by the European Directorate for V Quality of Medicines that its certificate of suitability for ranitidine hydrochloride has been suspended, it added.
GSK Pharma said it manufactures Ranitidine Hydrochloride IP Tablets in 150 mg and 300 mg (Zinetac) using API (Active Pharmaceutical Ingredient) from Saraca Laboratories Ltd and another supplier, SMS Lifesciences India Ltd, for supply to Indian market.