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[HEALTH] · Poland · 5 sources

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Poland bans Atorvastatin Medical Valley 40 mg over tablet defects

Poland’s Chief Pharmaceutical Inspectorate (GIF) issued an immediate nationwide ban on the cholesterol‑lowering drug Atorvastatin Medical Valley 40 mg. The regulator found quality defects in the tablet coating – unevenness and mechanical damage – that could affect the drug’s safety and efficacy. The decision, granted immediate enforcement, requires all pharmacies and wholesalers to stop distribution of every series of the product on the Polish market.

The medication, produced by Swedish company Medical Valley Invest AB in Höllviken, was sold in 30‑tablet packs (GTIN 05909991501662, marketing‑authorisation number 27496). Patients are advised to verify the product name and GTIN on their packaging, contact their prescribing physician, and switch to an alternative statin if they are using the withdrawn batches. The withdrawal is a standard regulatory measure when a medicinal product fails to meet quality standards.

Entities

Atorvastatin Medical Valley · Medical Valley Invest AB · Polish Chief Pharmaceutical Inspectorate