Biznes Fakty
Dexapini – a series of cough medicine suspended from sale
The Chief Pharmaceutical Inspector (GIF) has halted the distribution of a batch of a drug known as Dexapini across the nation. GIF received notifications from ten pharmaceutical wholesalers nationwide regarding the presence of crystalline sediment at the base of the bottle.
The Chief Pharmaceutical Inspector (GIF) has prohibited the sale of the medication Dexapini, Pini extractum fluidum + Foeniculi tinctura + Dextromethorphani hydrobromidum, (430 mg + 65 mg + 6.5 mg)/5 ml, syrup, packaged in: 1 bottle of 115 ml, GTIN 05909991031619, batch number: 02092024, expiration date: 30/09/2027 nationwide.
The responsible party is Polpharma Pharmaceutical Plant located in Starogard Gdański.
The decision made by GIF is effective immediately.
Reason for decision
Dexapini is utilized for treating dry cough associated with upper respiratory tract inflammation. This syrup is designed for both children and adults.
The Chief Pharmaceutical Inspector received alerts from ten pharmaceutical wholesalers from various regions, noting the observation of crystalline sediment at the bottom of the Dexapini bottle (batch number 02092024).
„The aforementioned feature is not mentioned in the product information as a natural characteristic of the item. According to the reported issues, concerning more than 1.7 thousand packages, the crystalline sediment did not dissolve when the bottle’s contents were agitated,” GIF stated.
Explanations provided by the responsible entity to the Chief Pharmaceutical Inspector confirmed the presence of large, clear crystals in archived samples of the specified batch of the medication. After examining the crystals, the entity identified that the crystallized substance was sucrose—a sugar that is an ingredient of the medication.
„The responsible party indicated the most likely cause for the phenomenon and outlined the corrective measures necessary to prevent future occurrences of sugar crystallization in the Dexapini product. The entity has taken steps to verify the appropriate quality of the medication within newly opened packages,” the justification for the decision states.
„However, due to the nature of the observed phenomenon highlighted by the responsible entity, namely a decrease in the preservative effectiveness of the solution as a result of reduced sugar concentration in the liquid portion of the medication consumed by the patient, the Chief Pharmaceutical Inspector believes that the microbiological purity of the medicinal product may not be preserved throughout the batch’s validity period. The extent of sugar loss in the liquid component of the medication is unspecified. Consequently, there exists a genuine risk of quality degradation of the affected batch of Dexapini syrup during its validity period, particularly after the initial opening of the package (bottle),” it was added.
Given the factual circumstances detailed above, GIF deemed it appropriate and necessary to suspend the sale of batch number 02092024 of the Dexapini medicinal product.
