Kuwait MoH withdraws from market products containing Raniditine

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KUWAIT CITY, Apr 2: Kuwait’s Ministry of Health said Thursday it was withdrawing all products containing Raniditine substance from the market, upon recommendations of the US Food and Drug Administration, because they contain large concentrations of residues of N-Nitrosodimethylamine (NDMA).


The MoH’s drug and herbal registration and supervision decided to withdraw the products for the sake of wellbeing of public, Dr. Abdullah Al-Bader, Assistant Undersecretary for pharmaceutical supervision, told KUNA.

This measure, he added, was upon recommendation of FDA following tests showing large concentration of N-Nitrosodimethylamine (NDMA) residues which could be harmful to patients if the medicine is exposed to overheating.

Al-Bader said his department had stopped in September 2019 registration of all medications containing Raniditine, used to decreases stomach acid production, until further examinations of suitable N-Nitrosodimethylamine (NDMA) levels.

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