The Spanish Agency for Medicines and Health Products (Aemps) has reported the withdrawal of the lote 1996A of the drug Sabrilex 500 milligrams granules for oral solution in its presentation of 50 sachets. This medication is used to control various forms of epilepsy.
The reason that Health uses for its withdrawal is the “possible presence” of traces of the drug tiapridewhich acts on the central nervous system.
This is stated in an informative note by Aemps, in which it warns that this quality “defect” “does not pose a vital risk to the patient” and adds that said batch has expiration date 31 May 2024 and was manufactured by Patheon France and marketed in Spain by Marion Merrell, SA
As regards the precautionary measures adopted, all the units distributed from the affected lot have been withdrawn from the market and returned to the laboratory “through the usual channels”.
Within the framework of this process, Aemps urges the autonomous communities to monitor the withdrawal.