GlaxoSmithKline Pharmaceuticals Ltd on Wednesday announced recall of ranitidine hydrochloride tablets produced in India using API sourced from Saraca Laboratories Ltd following detection of genotoxic nitrosamine NDMA by authorities.
The company has also decided to suspend release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations, GlaxoSmithKline Pharmaceuticals said in a regulatory.
GSK Pharma said it has been contacted by regulatory authorities regarding detection of genotoxic nitrosamine NDMA in ranitidine products.
Subsequently, Saraca Laboratories Ltd were notified by the European Directorate for V Quality of Medicines that its certificate of suitability for ranitidine hydrochloride has been suspended, it added.
GSK Pharma said it manufactures Ranitidine Hydrochloride IP Tablets in 150 mg and 300 mg (Zinetac) using API (Active Pharmaceutical Ingredient) from Saraca Laboratories Ltd and another supplier, SMS Lifesciences India Ltd, for supply to Indian market.
As a precautionary action, it has decided "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", the company said.
However, it said, the product manufactured using API from SMS Lifesciences India Limited will not be recalled at this point of time.
"However, all such products will remain on hold and they will not be released to the market while the company will await the test results," it added.
The company further said it is continuing with investigations into the potential source of the NDMA.
"These investigations include continued engagement with our API suppliers," the company said adding that Patient safety remains its utmost priority and the company is taking this issue very seriously.
Ranitidine hydrochloride is commonly used for treatment of ulcers of stomach and intestine.
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