The Chief Pharmaceutical Inspectorate (GIF) has withdrawn a group of drugs called Monover from circulation across the country. This decision was made due to the discovery of the presence of glass in a bottle of the product.
GIF has released from the market nationwide 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, date 2020-31-2020.
The responsible organization is Pharmacosmos A/S in Denmark.
GIF has banned the sale of the aforementioned series of drugs throughout the country.
Decisions are implemented immediately.
Glass was found in one of the bottles
The chief pharmaceutical inspector from the wholesale manager Medezin sp. It concerned the suspicions of non-compliance with the quality requirements of the medicinal product Monover (Ferricum derisomaltosum) 100 mg, solution for injection or infusion, with batch number 230504A-6 and an expiration date of May 31, 2026.
In one of the bottles above. the bottle was found, so the staff of the pharmacy of the Masovian specialist hospital. Joseph Pisarsky sent an application in Ostroleka.
During the inspection, it was confirmed by the pharmaceutical inspector of Masovian Voivodeship that in one bottle of “Monover” there was a large piece of glass, the size of which was about 1 centimeter, and the particles were stuck to the wall and the neck of the bottle. As stated by the Pharmaceutical Inspection of Masovia Voivodeship, there is a doubt that the medicinal material in question does not meet the quality requirements.
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The results of the investigation were presented to GIF. The justification of the decision indicates that the non-conformity was determined by the presence of glass fragments in the vial for batch 230504A-6 of the drug Monover, a solution of 100 mg Fe3+/ml for injection or infusion intended for the Polish market. .
The probable cause of the inconsistency was found to be a broken glass in the filling line, which was not detected during subsequent testing due to the size and shape of the glass particles and the dark brown color of the solution.
What is Monover and what is it used for?
Monover is a drug in the form of a solution for injection and infusion, which contains a combination of iron and derisomaltose. It is used to treat iron deficiency or iron deficiency anemia.
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