The Main Pharmaceutical Inspectorate has published a decision to withdraw two drugs from the market: Polyvaccinum mite – nasal drops and BDS N – nebuliser suspension.
GIF withdrew from the market:
1.BDS N (Budesonidum), nebuliser suspension, 0,125 mg / ml, 20 ampoules of 2 ml
- batch number: 1030518, expiry date: 31.03.2021
- batch number: 1030618, expiry date: 31.03.2021
Marketing authorization holder: Apotex Europe BV The Netherlands
The reason for the decision was to obtain results out of specification in the archival samples tested by the manufacturer, in terms of the parameter of the content of budesonide-related substances, due to the exceeded content of impurities.
2. Polyvaccinum mite, non-specific bacterial vaccine, nasal drops, suspension
- batch number: 01918002, expiry date: 06.2020
Entity responsible for the preparation: Instytut Biotechnologii Surowic i Szczepionek BIOMED SA
The reason for the decision was the finding of a quality defect. The sample of the medicinal product was inconsistent with the specifications of the MAH – in one of the bottles of the above-mentioned During the series, a solid was found floating on the surface of the suspension.
BDS N is a corticosteroid inhaler with anti-inflammatory properties. It is used in the regular, long-term treatment of bronchial asthma.
Polyvaccinum mite nasal drops are a bacterial vaccine that protects against recurrent infections of the upper respiratory tract and contains inactivated bacteria.
Source: GIF