A popular drug is disappearing from the market. It may pose a health risk to patients. Do you have it in your medicine cabinet?

Pills on hand Source: Unsplash

The Chief Pharmaceutical Inspectorate has issued an urgent advisory regarding a popular drug taken by many Poles. The product may be ineffective and poses a health risk. Learn more.

The warning issued by the Chief Pharmaceutical Inspectorate concerns a product called Seronil. This medication is used to treat patients with major depression and obsessive-compulsive disorder. It is prescribed to both adults and children (after the age of eight). The medication is classified as a selective serotonin reuptake inhibitor (SSRI). Find out why it was withdrawn from pharmacies.

Seronil – details of the withdrawn drug

The Chief Pharmaceutical Inspector has withdrawn Seronil from the market because the drug does not meet the requirements set out in its specification. "The identified discrepancy in the content of the N-nitroso fluoxetine impurity indicates a loss of quality specified for this drug, which may impact its efficacy and safety. The established acceptance criterion for the content of the aforementioned impurity has been exceeded. Therefore, a risk to human health resulting from leaving the batches of the medicinal product in question on the market cannot be ruled out," reads a statement released by the Chief Pharmaceutical Inspectorate. Seronil, Fluoxetin (10 mg) film-coated tablets have been withdrawn from pharmacies:

packaging: 30 pieces, GTIN 05909990374311 within the series

number 2177338, expiry date 31/08/2026,
number 2177335, expiry date 31/08/2026,
number 2170573, expiry date 31/07/2026,
number 2170570, expiry date 31/07/2026,
number 2170574, expiry date 30/06/2026,
number 2165890, expiry date 30/06/2026,
number 2165891, expiry date 30/06/2026,
number 2155889, expiry date 30/04/2026
number 2155891, expiry date 30/04/2026,
number 2155887, expiry date 28/02/2026,
number 2148990, expiry date 28/02/2026,
number 2148993, expiry date 28/02/2026,
number 2142370, expiry date 30/11/2025,
number 2142373, expiry date 30/11/2025,
number 2142366, expiry date 30/11/2025,
number 2139751, expiry date 30/11/2025,
number 2132807, expiry date 31/10/2025,
number 2129812, expiry date 31/10/2025,
number 2127577, expiry date 30/09/2025,
number 2125324, expiry date 30/09/2025;

pack of 100 pcs, GTIN 05909990374328 in the series:

number 2177351, expiry date 31/08/2026,
number 2177349, expiry date 31/08/2026,
number 2177345, expiry date 31/08/2026,
number 2177343, expiry date 31/07/2026,
number 2165879S1, expiry date 30/06/2026,
number 2165880S1, expiry date 30/06/2026,
number 2165623S1, expiry date 30/06/2026,
number 2165878S1, expiry date 30/06/2026,
number 2165889, expiry date 30/06/2026,
number 2155900, expiry date 30/04/2026,
number 2155896, expiry date 30/04/2026,
number 2155893, expiry date 30/04/2026,
number 2155892, expiry date 30/04/2026,
number 2148605, expiry date 28/02/2026,
number 2148604, expiry date 28/02/2026,
number 2148603, expiry date 28/02/2026,
number 2148601, expiry date 28/02/2026,
number 2142375, expiry date 30/11/2025,
number 2139752, expiry date 30/11/2025,
number 2139754, expiry date 30/11/2025,
number 2132809, expiry date 31/10/2025,
number 2132812, expiry date 31/10/2025,
number 2130194, expiry date 31/10/2025,
number 2129819, expiry date 31/10/2025,
number 2129817, expiry date 31/10/2025,
number 2127575, expiry date 30/09/2025,
number 2126763, expiry date 30/09/2025,
number 2125326, expiry date 30/09/2025,
number 2125325, expiry date 30/09/2025;

The responsible entity is Orion Corporation, based in Espoo, Finland. The Chief Pharmaceutical Inspector's decision covers the entire country. The Chief Pharmaceutical Inspectorate not only withdrew the defective product from pharmacies but also banned its introduction to the Polish market. The decision was made immediately enforceable.

What is "major depression"?

Major depressive disorder (MDD) originates from within the individual, not from external factors such as prolonged stress, the death of a loved one, job loss, divorce, or serious illness. It develops without a clear cause. Its symptoms can vary. It is typically characterized by a prolonged low mood, a significant decrease in concentration, or a sense of hopelessness. These symptoms are accompanied by a loss of interest in activities that the patient once enjoyed. It is estimated that over 1.2 million Poles suffer from depression.