The National Authority of Medicines and Health Products (Infarmed) has mandated the immediate suspension of sales for certain batches of the antidepressant Fluoxetine Generis 20 mg Capsules. This action follows a voluntary recall issued by the company Generis Farmacêutica, S.A.
Infarmed reports that the recall stems from an analytical result which exceeded acceptable limits for an impurity.
“Generis Farmacêutica, S.A. will conduct a voluntary recall of the batches listed below of Fluoxetine Generis 20 mg Capsules due to the detection of an analytical result above acceptable limits for an impurity,” states an informative circular dated March 28.
The affected batches are: 22FN115A; 22IN136A; 22LN092A; 23CN003A; 23FN079A; 23FN080A; 23KN161A; 24BN149A; 24EN095A; 24EN096A; 24IN127A.
As a result, Infarmed has ordered the “immediate suspension of the sale of these batches.”
Given this situation, Infarmed advises that “entities possessing these batches in stock must not sell, dispense, or administer them and should proceed with their return.” Patients who are using medications from these batches “should not stop treatment” and are advised to “contact their doctor as soon as possible to switch to another batch or an alternative medication.”
