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[HEALTH] · Poland · 3 sources

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Chief Pharmaceutical Inspectorate recalls popular drug batch

The Chief Pharmaceutical Inspectorate has ordered the immediate withdrawal of a specific batch of a popular medicinal product from pharmacies and wholesalers across Poland. The decision follows quality testing by the National Institute of Medicinals, which revealed that batch KV023 failed to meet requirements regarding the magnesium release parameter within a 90-minute window.

Experts noted that improper release rates of active substances can compromise the efficacy and absorption of the medication. While the manufacturer, Opella Healthcare Poland, disputes the findings—suggesting discrepancies may stem from differences in laboratory equipment used during testing—the Inspectorate maintained that the state laboratory results provide sufficient grounds for the recall to ensure patient safety.

Entities

Chief Pharmaceutical Inspectorate · National Institute of Medicinals · Opella Healthcare Poland