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2 clusters · 5 sources · 13 days · First seen · Last updated

Pharmaceutical product recalls in Poland

Overview

The Chief Pharmaceutical Inspectorate (GIF) in Poland has issued urgent decisions to withdraw or suspend several medicinal products from the market due to quality concerns.

One decision involves the immediate withdrawal of a specific batch of FluoxetynaEGIS (Fluoxetinum) 10 mg hard capsules (batch T239A1123, expiring November 2026). The withdrawal is due to a failure to meet active ingredient content specifications. The manufacturer suggested the issue stemmed from variability in capsule fill mass rather than mixture inhomogeneity.

Additionally, the GIF has suspended the circulation of all batches of the contraceptive medication Symonette (Desogestrelum) 75 micrograms, produced by Farmak International. Following testing by the National Institute of Drugs, it was determined that the product failed to meet quality requirements regarding the release of desogestrel within 15 minutes. The regulator noted that falling below the specified lower limit for active substance release poses a risk to the drug’s efficacy.

Entities

Chief Pharmaceutical Inspectorate · National Institute of Drugs · Farmak International · Egis · G. L. Pharma GmbH

Timeline

  1. [HEALTH] 3 sources
    Poland's Chief Pharmaceutical Inspectorate recalls drugs

    The Polish Chief Pharmaceutical Inspectorate has ordered the withdrawal of a fluoxetine batch and the suspension of all Symonette contraceptive tablets due to quality and efficacy concerns.

  2. [HEALTH] 2 sources
    Balfumon 120 mg drug sale suspended in Poland

    Poland's Chief Pharmaceutical Inspectorate has suspended the sale of Balfumon 120 mg (14-capsule packs) due to concerns regarding the release rate of its active substance.

Sources

moj.powiat.pl · punjabilok.com · rynekzdrowia.pl · wiescirolnicze.pl · zdrowie.co.pl