Loperamid APTEO MED
GIF decision: Marketing suspension
What does this decision mean?
- • Wstrzymanie w obrocie — The product has been temporarily suspended from circulation — sales are paused pending clarification, but it is not a full market recall.
Out-of-specification (OOS) results were found for the "active substance content" parameter during stability testing of selected batches of Loperamide APTEO MED 2 mg, raising justified doubts as to whether they meet quality requirements. Potential effects: lack of efficacy in diarrhoea treatment.
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