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Brains Bioceutical Corp Enters USD $490 Billion USA Pharmaceutical Market by way of DMF from US FDA

Brains Bioceutical Corp Enters USD $490 Billion USA Pharmaceutical Market by way of DMF from US FDA
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Brains Bioceutical Corp Enters USD $490 Billion USA Pharmaceutical Market by way of DMF from US FDA

Brains Bioceutical Corp Enters USD $490 Billion USA Pharmaceutical Market by way of DMF from US FDA
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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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