The National Medicine Authority (Infarmed) has ordered the immediate suspension of the sale of specific batches of the antidepressant Fluoxetina Generis 20 mg Capsules, following a voluntary recall by Generis Farmacêutica, S.A.
This decision, outlined by Infarmed in an informational circular dated August 7, is due to the detection of an analytical result exceeding acceptable limits for an impurity.
The affected batches are 24BN150A, with expiry in March 2027, 24IN128A, expiring in September 2027, 24KN015A, expiring in November 2027, and 24KN014A, also expiring in November 2027.
Infarmed warns that entities possessing these batches must not sell, dispense, or administer them and should proceed with their return.
Patients using medications from these batches should not stop their treatment. As soon as possible, they should contact their doctor to assess whether replacement with an alternative medication is necessary.
