GIF withdraws from pharmacies a well -known antiviral syrup. I am talking about risk
GIF informed on Wednesday, June 4 that he suspends the trade in the medical product called Inuprin Forte (Inosinum Pranobexum), 100 mg/ml, syrup, 1 bottle 100 ml throughout the country. These are the specific numbers of the series, which we provide later in the article. – The Chief Pharmaceutical Inspectorate and Provincial Pharmaceutical Inspectorates were received by applications regarding the suspicion of not meeting the quality requirements of this medicinal product – explains Łukasz Pietrzak, Chief Pharmaceutical Inspector.
The Chief Pharmaceutical Inspector diligently withdrew popular syrup from the market
The reason for the above -mentioned entries was the statement of the presence of an insoluble settlement in the form of crystals at the bottom of the product bottles. In the course of the explanatory proceedings, the occurrence of the irregularities described above in the packaging of products on the storage states of pharmacies making applications was confirmed
– explains the head of GIF.
He adds that the preliminary explanations given by the responsible entity showed that the observed sediment was a precipitating sucrose – an auxiliary substance that is a component of the product. He explained that the process of precipitating sediment is a physicochemical phenomenon that may occur during storage. He also argued that the presence of sediment does not affect the quality, effectiveness or safety of the use of the product.
Inuprin Forte withdrawn from pharmacies. Does not meet quality standards?
Solinea Sp. z o. o. at the same time assured that she was working on introducing appropriate changes aimed at limiting the precipitation of the sediment and improving the appearance of the product.
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The responsible entity informed about the intention to add information to the characteristics of the medicinal product about the possibility of precipitating sucrose in the form of crystals. In addition, he reported that research began taking into account, among others Research studies of antimicrobial protection, including research, which will allow confirmation of the effectiveness of preservatives used in the product after opening, as well as a product examination containing a reduced amount of sucrose in terms of antimicrobial protection to show that the reduced sucrose content will not affect the preservative effectiveness
– says Łukasz Pietrzak in a message.
GIF protects patients. « Risk cannot be ruled out »
It turned out that the reservations apply to 15 series of this product.
A premise for suspending the turnover of the abovementioned A series of medicinal product is justified by the suspicion that they do not meet the qualitative requirements set for him, due to the precipitating sediment in the form of crystals at the bottom of the bottle. At the moment, there is no information in information prints about the possibility of sediment at the bottom of the bottle of the product in question and information about the lack of a change in the quality of the drug in the event of observing such a phenomenon. In addition, the lack of influence of the reduced content of sucrose in syrup cannot be ruled out, due to its crystallization, the effectiveness of its preservative action and microbiological purity during its storage, and especially after its opening.
– explains his decision to withdraw the syrup from trading the Chief Pharmaceutical Inspector.
Pietrzak adds that because potential disorder in the effect of the drug cannot be ruled out, hence the decision of immediate enforceability. GIF has the right to take it when there is a risk for people.
The explanations provided by the responsible entity cannot be considered by the authority as sufficient evidence of the lack of influence of the identified irregularities on the quality, effectiveness and safety of the use of a medicinal product, in the case of these series in the circulation. For the above reasons, the Chief Pharmaceutical Inspector decided that for the protection of the health and life of patients who could accept a medicinal product that does not meet qualitative requirements, it was justified and it was necessary to grant this decision of immediate enforceability
– argue Pietrzak.
These Inuprin Forte syrup series have been withdrawn from pharmacies
Series number: 03101712, expiry date: 09.2025
Series number: 04101712, expiry date: 09.2025
Series number: 05101712, expiry date: 09.2025
Series number: 02111712, expiry date: 10.2025
Series number: 05111712, expiry date: 10.2025
Series number: 07111712, expiry date: 10.2025
Series number: 08111712, expiry date: 10.2025
Series number: 09111712, expiry date: 10.2025
Series number: 10111712, expiry date: 10.2025
Series number: 11111712, expiry date: 10.2025
Series number: 12111712, expiry date: 10.2025
Series number: 02121712, expiry date: 11.2025
Series number: 03121712, expiry date: 11.2025
Series number: 04121712, expiry date: 11.2025
Series number: 01021713, expiry date: 01.2026
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The reason is reservations about the quality.
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The designated parts of the syrup must disappear from pharmacies.
