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Date Published: 14/05/2025

Spain issues urgent recall of popular antidepressant

The Spanish Agency for Medicines has detected impurities in a very common mental health drug

The Spanish Agency for Medicines and Health Products (AEMPS) has issued an urgent recall of several batches of the antidepressant medication duloxetine due to a detected quality defect.

Although the defect does not pose a risk to patients' lives, AEMPS has deemed it necessary to remove the product from pharmacies as a precautionary measure.

The affected medication is duloxetine, manufactured by Pensa Pharma, which is packaged in a 28-capsule blister pack of 30mg gastro-resistant hard capsules. The manufacturer, Towa Pharmaceutical Europe SL, is registered in Martorelles, Barcelona. The specific batch number affected is 240803, with an expiration date of November 30, 2026.

Duloxetine is an active ingredient that functions by increasing serotonin and norepinephrine levels in the nervous system. It is commonly used to treat depression, generalised anxiety disorder and diabetic neuropathic pain, characterised by burning, stabbing or electric shock-like sensations.

In general, the presence of impurities in medications can compromise their efficacy, stability and safety. Impurities can cause undesirable changes in the product's appearance, odour or flavour and may even render the medication toxic or incompatible with certain substances.

However, AEMPS has emphasised that the specific impurities detected in the affected batch of duloxetine do not pose a life-threatening risk to patients.

Nevertheless, as a precautionary measure, AEMPS has instructed that all distributed units of the affected batch be withdrawn from the market and returned to the laboratory. Local governments will be responsible for monitoring the recall to ensure that no units remain in the distribution chain or at dispensing points.

In other news: The new overtime rule that Spanish workers have been waiting for

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