In a statement released on 9 September, Infarmed said that "Generis Farmacêutica, S.A. will voluntarily recall batch no. 21032, with expiry date 01/2023, of the drug Lorazepam Labesfal, 1 mg, tablet, with registration number 5615927, because an out-of-specification result was detected in the dosing test during ongoing stability studies.
In light of the problem detected, Infarmed determined "the immediate suspension of the commercialisation of this batch", which means that "entities with this batch of medicine in stock cannot sell, dispense or administer it, and must return it".
"Patients who are using medicines belonging to this batch should not interrupt their treatment. As soon as possible, they should contact their doctor to replace it with another batch or an alternative medicine", the statement adds.