The National Authority for Medicines and Health Products (Infarmed) announced on Monday the “voluntary” recall of batches of the antidepressant Fluoxetine toLife (20 mg), effectively suspending its sale.
In an official statement, Infarmed explains that Towa Pharmaceutical, S.A will “voluntarily recall batch no. 23KN163A of the medication Fluoxetine toLife 20 mg capsules, containing 60 units, with the registration number 5223284.”
This recall is due to “an analytical result exceeding acceptable limits for an impurity” found.
Consequently, the authority has ordered the “immediate suspension of the sale of this batch” and states that “entities with this batch in stock cannot sell, dispense, or administer it, and should proceed with its return.”
Patients using medications from this batch are advised “not to interrupt their treatment.” However, “as soon as possible, they should contact their doctor to assess the necessity of substitution with an alternative medication.”
