British drugmaker GlaxoSmithKlineNSE -1.10 % on Wednesday said it is recalling heartburn drug Ranitidine from India, a day after the country’s drug regulator asked pharma companies to check their products for carcinogen.
“As a precautionary action, GSK has made the decision to initiate a voluntary recall (pharmacy/retail level recall) of Zinetac Tablets 150 mg and 300 mg products manufactured in India using API sourced from Saraca Laboratories Ltd,” a GSK spokesperson said in a statement.
Earlier this month, the US FDA had raised a global alarm over the presence of a probable cancer causing substance—NDMA or N-Niteosodimethylamine—in some Ranitidine medicines.
GSK manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using API from Hyderabad-based Saraca Laboratories and another supplier, SMS Lifesciences India Ltd, for supply to the Indian market.
Subsequently, Saraca Laboratories was notified by the European Directorate for the Quality of Medicines (EDQM) that its certificate of suitability for Ranitidine Hydrochloride has been suspended with immediate effect.
GSK has been contacted by the Indian drug regulatory authority regarding the detection of genotoxic nitrosamine NDMA in Ranitidine products.
