GlaxoSmithKline Pharmaceuticals announced that the company has decided to discontinue the manufacture and supply of Zinetac tablets, used to treat and prevent heartburn.
The company has made a decision to discontinue the manufacture and supply of Zinetac tablets (150 mg and 300 mg products) manufactured in India and will in due course request cancellation of the marketing authorisation associated with the drug, GlaxoSmithKline Pharmaceuticals said.
GSK had earlier announced that it was contacted by regulatory authorities regarding the detection of NDMA in Zantac (ranitidine) products.
Based on the information received and correspondence with regulatory authorities, the company made the decision in September 2019 and extended it in October 2019, to initiate a voluntary pharmacy/retail level recall in all markets of all Zantac products manufactured using all API sources, as a precautionary action.
The recall also applied to all ranitidine products (Zinetac 150mg / 300mg tablets) marketed by GSK in India. Further follow on disclosures in relation to the financial impact of the voluntary, recall were also made on 3 February 2020.
GSK has continued to respond to the queries received from the regulatory authorities and to work actively with them to address their concerns. GSK has been conducting investigations into the potential source of the NDMA.
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