Thursday , February 9 2023

ANSM recalls a batch of valproate drugs – 17/01/2019



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ANSM recalls a batch of valproate drugs

ANSM recalls a batch of valproate drugs

valproate: Depakine 200 mg / ml oral solution and sodium Valproate Zentiva 200 mg / ml oral solution. In the discussion, the dose on the pipette for drug administration is potentially false.

This recall in the batch follows the presence of a pipette containing a dose of 300 mg / ml (a dose marketed in France) instead of a 200 mg / ml pipette, resulting in a subdose in a patient. According to the Sanofi-Aventis France laboratory, this defect only concerns some of the 88,000 boxes in the batch 013 097 distributed in France between February and August 2018.

If you have a box belonging to this batch, do not stop the treatment. Take it back with the pipette to the pharmacy as soon as possible.

" In patients using the wrong pipette for drug administration, valproate may be underdose leading to decreased efficacy of anti-epileptic therapy ", Warns ANSM." These patients should go to the pharmacy as soon as possible to get a free box from another lot. They also need to approach their doctor as soon as possible to evaluate the balance of anti-epileptic treatment. "

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