GSK de­cides to re­call pop­u­lar antacid over con­cern

The Times of India (New Delhi edition) - - Times Nation - Ru­pali.Mukher­jee @times­

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.”

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