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The Main Pharmaceutical Inspectorate decided to withdraw from the market a series of Benodil (Budesonidum) nebulization suspension used, inter alia, in in the treatment of asthma or exacerbation of chronic obstructive pulmonary disease.
GIF decided to withdraw from the market a batch of Benodil (Budesonidum) – nebuliser suspension, 0,125 mg / ml, 20 ampoules of 2 ml with lot number: 1031518 and expiry date: 09.2021.
The reason for the decision to recall the Benodil series was the finding of a quality defect. GIF informed that the Inspectorate received an application from the MAH to recall a specific batch of a medicinal product due to exceeding the specification limit for the parameter of related substances content.
Benodil is a drug used to treat asthma (when the use of a pressurized or dry powder inhaler is inappropriate), pseudo-croup (very severe inpatient laryngitis), exacerbation of chronic obstructive pulmonary disease (COPD) when the use of budesonide nebuliser suspension is appropriate . The preparation is not indicated for the relief of an acute attack of asthma or asthmatic and apnea conditions.
The medicinal product in question comes from Zakłady Farmaceutyczne Polpharma SA with its seat in Starogard Gdański.
Source: GIF