Drug manufacturer Infarmed initiates the recall of numerous Fluoxetine Generic antidepressant products from the marketplace
The National Authority of Medicines and Health Products has announced the withdrawal of several batches of Fluoxetina Generis 20 mg from the market following a voluntary recall by the manufacturer, Generis Farmacêutica, S.A. This action is due to the detection of nitrosamine impurities in the medication, which are potential carcinogens.
The affected batches, identified as 24BN150A, 24IN128A, 24KN015A, and 24KN014A, are still in stock and should not be used. Patients who are currently using medications from these batches are urged to contact their doctor as soon as possible to replace their medication with another batch or an alternative medication. It is important not to discontinue treatment without medical advice.
The medicines authority has not provided any information on the potential risks associated with continuing to use the medications from the specified batches or on the steps that entities should take to return the medications. They have also not specified any alternative medications for patients who are currently using the medications from the specified batches.
Fluoxetina Generis 20 mg is a medication used for the treatment of depression. The recall is due to an analytical result above acceptable limits for an impurity detected in several batches of the medication.
Healthcare professionals are also notified to assist patients appropriately in managing their medication during this recall period. No specific details on symptom management or substitution products are provided in the available search results, but the general precaution is immediate discontinuation of the recalled batches and medical consultation.
This approach aligns with standard safety measures for nitrosamine-related recalls in pharmaceuticals. The recall notice is available on the website of the Infarmed. The medicines authority has not provided any information on the consequences for entities that fail to comply with the appeal or on the timeline for the replacement of the medications from the specified batches.
In summary, the recall of Fluoxetina Generis 20 mg is due to the presence of nitrosamine impurities, which are potential carcinogens. Patients using medications from the affected batches are advised to stop using the medication immediately, consult a healthcare provider, do not discontinue without medical advice, and seek support from pharmacists or the manufacturer for alternatives. The recall notice was issued by the company Generis Farmacêutica, S.A. themselves.
Patients should replace their Fluoxetina Generis 20 mg from the affected batches due to the potential risks associated with nitrosamine impurities, which are known to be potential carcinogens. It's crucial to consult a healthcare professional for alternative medication options, as discontinuation without medical advice is not advisable.
The recall of Fluoxetina Generis 20 mg is relevant to the broader field of health-and-wellness, including mental health, given its role in the treatment of depression. Stakeholders such as healthcare providers and pharmacists should be aware of this recall and assist patients in managing their medication during this period.
