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GIF has withdrawn a batch of Monover from the market

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The Chief Pharmaceutical Inspector (GIF) withdrew one batch of the drug called Monover from the market throughout the country. The decision was made due to the detection of the presence of glass in one vial of the product.

GIF withdrew from the market throughout the country a medicinal product called Monover (Ferricum derisomaltosum) 100 mg Fe3+/ml, solution for injection and infusion, 5 vials of 5 ml GTIN 05909990775446, batch number: 230504A-6, expiry date: 2026-05 -31.

The responsible entity is Pharmacosmos A/S with its registered office in Denmark.

GIF banned the marketing of the above-mentioned series of the medicinal product throughout the country.

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Decisions are immediately enforceable.

Glass was found in one of the vials

The Chief Pharmaceutical Inspector received a notification from the manager of the pharmaceutical wholesaler Medezin sp. z o. o. This concerned suspicions of failure to meet the quality requirements of the medicinal product Monover (Ferricum derisomaltosum) 100 mg, solution for injection or infusion, with batch number 230504A-6 and expiration date of May 31, 2026.

In one of the vials above. glass was found in the product, so the staff of the hospital pharmacy of the Masovian Specialist Hospital. Józef Pisarski in Ostrołęka sent an application.

During the inspection of the Masovian Voivodeship Pharmaceutical Inspector, it was confirmed that in one vial of the Monover medicinal product there was a visible large piece of glass, approximately 1 cm in size, and particles visible on the walls and neck of the vial. As stated by the Masovian Voivodeship Pharmaceutical Inspectorate, there is a suspicion that the medicinal product in question does not meet the quality requirements set for it.

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The results of the investigation have been submitted to GIF. The justification for the decision shows that the non-compliance involving the presence of pieces of glass in the vial was identified for the batch 230504A-6 medicinal product Monover, 100 mg Fe3+/ml solution for injection or infusionintended for the Polish market.

The probable cause of the non-compliance was found to be a broken vial on the filling line which, due to the size and shape of the glass particles and the dark brown color of the solution, was not detected during subsequent inspection.

What is Monover and what is it used for?

Monover is a medicine in the form of a solution for injection and infusion that contains a combination of iron and derisomaltose. It is used to treat iron deficiency or iron deficiency anemia.

Main photo source: Shutterstock



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