Fluoxetine EGIS antidepressant recalled in Poland

The Chief Pharmaceutical Inspectorate in Poland has issued an immediate recall for a specific batch of the antidepressant Fluoxetine EGIS (10 mg, hard capsules, 28-count packs). The recall affects batch number 4914A0125, with an expiration date of 01.2028.

The decision follows a long-term stability study that revealed the active ingredient content was below the required specification limits. The manufacturer, Egis Pharmaceuticals PLC, identified the root cause as a localized filling error occurring at the beginning of the production run, likely due to manual adjustments of the filling chamber height.

While the manufacturer argued that the defect was limited to the initial capsules of the batch and that the variations were clinically insignificant, the Inspectorate rejected this reasoning. The regulator stated that the medicinal product must meet quality specifications in its entirety rather than in a limited capacity, and noted that the lower active ingredient content could lead to lower-than-expected efficacy.