The issue concerns batch number 23.109 of the medication Lorazepam Labesfal, 1 mg, tablet, 60 units, with registration number 5.615, according to the National Authority of Medicines and Health Products (Infarmed) in an informative circular published on their website.
Infarmed states that the company Generis Farmacêutica will proceed with a voluntary recall of this batch “due to an out-of-specification result detected in the dosage parameter during a stability study.”
Given this information, Infarmed has ordered the immediate suspension of its commercialization and appeals to entities that have this batch of medication in stock not to sell, dispense, or administer it, and to proceed with its return.
“Patients who are using medications from this batch should not interrupt their treatment and should contact their doctor as soon as possible to replace it with another batch or an alternative medication,” recommends the medicine authority.