GSK decides to recall popular antacid over concern
Mumbai: The market leader of popular antacid medicine ranitidine in India, GSK, said it has initiated a recall of its Zinetac tablets (150mg and 300mg), from pharmacies and retail outlets across India.
The recall follows a directive by Drugs Controller General of India to state regulators and pharma companies on September 24, to verify the safety of the widelysold anatacid and take measures to ensure patients’ safety, as reported by TOI. GSK manufactures ranitidine using API (active pharmaceutical ingredient) from Saraca Laboratories and SMS Lifesciences India, for supply in the Indian market. The voluntary recall will cover the tablets which use raw materials from Hyderabadbased Saraca Laboratories. However, the product manufactured using API from SMS will not be recalled.
Saraca was notified by the European Directorate for Quality of Medicines that its certificate of suitability for ranitidine hydrochloride has been suspended with immediate effect. A GSK official told TOI, “The firm has been contacted by regulatory authorities regarding the detection of genotoxic nitrosamine NDMA in ranitidine products. GSK made the decision to suspend the release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, as a precautionary action, pending the outcome of ongoing tests.”
Full report on www.toi.in