Anyone using suspect batch should contact doctor ASAP
INFARMED, Portugal’s national medicines authority, has ordered the immediate suspension of a batch of the drug Lorazepam, indicated for the treatment of anxiety, due to the detection of an irregular result in a stability study, it says on its website.
At issue is batch number 23,109 of the drug Lorazepam Labesfal with 60 tablets of 1 milligram each, with registration number 5,615, says the National Authority of Medicines and Health Products in an information circular.
The company that marketed the batch, Generis Farmacêutica, is voluntarily recalling it “because an out-of-specification result was detected in the dosage parameter as part of a stability study.”
In view of this, INFARMED has ordered the immediate suspension of sale of this batch of the medicine, calling on any entities that have it in stock to return it.
“Patients who are using medicines belonging to this batch should not interrupt treatment but should contact their doctor as soon as possible to replace them with another batch or an alternative medicine,” recommends the medicines authority.
Source: LUSA
