The Chief Pharmaceutical Inspector (GIF) suspended the trade in a medicinal product called Benodil throughout the country. The reason for the decision is the possible occurrence of a quality defect.
The Chief Pharmaceutical Inspector published a decision to suspend the trade throughout the country of a medicinal product called: Benodil (Budesonidum), 0.25 mg/ml, nebulization suspension, package of 10 ampoules of 2 ml, GTIN: 05903060614284, batch number 054223, expiry date validity 03/2026
The responsible entity is Zakłady Farmaceutyczne POLPHARMA SA in Starogard Gdański.
The decision is immediately enforceable.
Reason for drug withdrawal
According to GIF, on November 9, 2023, the Main Pharmaceutical Inspectorate received information from the Masovian Voivodeship Pharmaceutical Inspector in Warsaw about two reports of suspected quality defects of the Benodil medicinal product.
“The notifications in question included information that the outer packaging (carton) of the indicated medicinal product contains immediate packaging (ampoules) with a label indicating that it is the medicinal product Budixon (Budesonidum) Neb 0.5 mg/ml, for which the responsible entity is Adamed Pharma SA The batch number on the outer packaging and on the immediate packaging was the same and indicated batch no. 054223, expiration date: 03/2026,” we read in the GIF announcement.
In the course of the explanatory proceedings, the Chief Pharmaceutical Inspector determined and confirmed that:
– both medicinal products indicated are manufactured at the same manufacturing site located in Italy;
– both medicinal products indicated above contain the active substance budesonide;
– the medicinal product Budixon (Budesonidum) Neb 0.5 mg/ml has not been manufactured and placed on the market under batch number 054223, expiry date: 03/2026 for any of the registered package sizes;
– the medicinal product Benodil (Budesonidum), 0.25 mg/ml, nebulization suspension, package of 10 ampoules of 2 ml is traded throughout the country.
As we read in the justification for the decision, in the event of a justified suspicion that a medicinal product does not meet the requirements set for it, or if there is a suspicion that the medicinal product has been falsified, the voivodeship pharmaceutical inspector issues a decision to suspend the marketing of specific batches of the medicinal product in its area of ​​operation.
The materials available to the Chief Pharmaceutical Inspector show that, in relation to the Benodil medicinal product, either immediate packaging (ampoules) of another medicinal product manufactured at the same manufacturing site was placed or incorrect labeling of immediate packaging (ampoules) containing the product indicated on the packaging external by affixing labels relating to another medicinal product manufactured at the same manufacturing site.
The Chief Pharmaceutical Inspector indicated that regardless of which of the situations described above occurred, any of them raises a justified suspicion that the Benodil medicinal product does not meet the quality requirements set for it, and therefore a premise for suspending the trade in this medicinal product – in the scope of the batch, as to where such suspicion exists.
The suspension is intended to protect patients from using a medicinal product potentially suffering from a quality defect for the duration of further explanatory proceedings conducted by the Chief Pharmaceutical Inspector – in particular with regard to determining the actual nature of the irregularity, as well as the causes and scope of its occurrence.
What is Benodil
Benodil is an anti-inflammatory inhaled medicine that contains a corticosteroid. It is used in regular, long-term treatment of bronchial asthma. This agent reduces swelling and irritation of the lower respiratory tract. This translates into a reduction in the frequency and severity of bronchial asthma symptoms.
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