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CDSCO declares 62 drug samples as substandard; Mankind Pharma, Bharat Biotech come under scanner

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Full list of medicines affected as Ireland faces major shortages

Full list of medicines affected as Ireland faces major shortages
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Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 500mg Gastro-Resistant Tablets, EL (22)A/09

Class 4 Medicines Defect Information, Syonell 250mg Gastro-Resistant Tablets,(PL 35507/0191), Syonell 500mg Gastro-Resistant Tablets, (PL 35507/0192), EL (21)A/11

Brief description of the problem Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to the incorrect amount of active pharmaceutical ingredient (valproate semisodium) printed on the outer packaging. Labelling on the current packaging Correct labelling on the packaging Syonell 250mg Gastro-Resistant Tablets. Each gastro-resistant tablet contains 250mg of valproate semi sodium Syonell 250mg Gastro-Resistant Tablets. Each gastro-resistant tablet contains 269.06mg of valproate semisodium equivalent to 250mg of valproic acid Syonell 500mg Gastro-Resistant Tablets. Each gastro-resistant tablet contains 500mg of valproate semi sodium

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