GlaxoSmithKline Pharmaceuticals Ltd. (GSK) on Thursday said it had voluntarily recalled Ranitidine hydrochloride tablets produced in India following alleged detection of genotoxic nitrosamine NDMA by global and Indian regulatory authorities. It is a global recall including in India.
“GSK has been contacted by regulatory authorities regarding the detection of genotoxic nitrosamine NDMA in ranitidine products. Based on the information received and correspondence with regulatory authorities, GSK made the decision to suspend the release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India,” GSK said in a statement.
“The recall is a precautionary action pending the outcome of ongoing tests and investigations,” it said.
The raw material used in the tablets were supplied by Saraca Laboratories Ltd. Thus, the European Directorate for the Quality of Medicines (EDQM) has suspended its certificate of suitability for ranitidine hydrochloride issued to Saraca with immediate effect.
GSK manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using API from Saraca and SMS Lifesciences India Ltd., for supply to Indian market.
“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,” GSK said. The product manufactured using API from SMS will not be recalled. However, all such products will remain on hold while the test results are awaited.
‘Patient safety’
“GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with our API suppliers. Patient safety remains our utmost priority and we are taking this issue very seriously,” it added. The market for Ranitidine anti-acidity product is worth ₹700 crore, including ₹200 crore of GSK. It is learnt that other manufacturers are still selling the tablets under different brands.
