Popular Painkiller Suspended From Sales. Check Your Medicine Cabinet for It
The Chief Pharmaceutical Inspector (GIF) has issued an important announcement regarding a popular painkiller. The preparation does not meet quality requirements. Learn the details of the decision.
The decision issued by the Chief Pharmaceutical Inspector concerns a painkiller and antipyretic drug called Paracetamol Aflofarm. This product is used to treat colds and flu in children. The preparation is also used to eliminate pain of various origins, for example those occurring during teething.
Paracetamol Aflofarm – GIF decision details
The Chief Pharmaceutical Inspector (GIF) announced the suspension of sales of the painkiller. In the released statement, he provided more details about the preparation. His decision concerns all series of the product Paracetamol Aflofarm (Paracetamolum):
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drug form: oral suspension,
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packaging: 120 mg/5 ml, (1 bottle 100 ml)
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GTIN: 05909991076115.
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Responsible entity: Aflofarm Farmacja Polska sp. z o. o. with its registered office in Pabianice
The decision applies to the entire country. It has been given immediate enforceability.
Why was sales of the painkiller stopped?
The decision of the Chief Pharmaceutical Inspector is related to reports received by the State Pharmaceutical Inspection. They drew attention to the appearance of sediment at the bottom of the bottle with the preparation, despite repeated shaking. GIF ordered appropriate tests to be carried out. They confirmed the existence of the indicated problem.
The evidence collected at this time indicates that the identified inconsistency consisting in the inability to obtain a homogeneous suspension when shaken may lead to sediment remaining at the bottom of the packaging and inconsistency in the content of the active substance in a single dose of the drug, and this inconsistency may apply to all product batches in circulation. Due to the above considerations, in view of the justified suspicion of the Chief Pharmaceutical Inspector that the batches of the medicinal product Paracetamol Aflofarm (Paracetamolum) (…) in circulation do not meet the quality requirements established for them, it has become necessary and justified to suspend their circulation – we read in the announcement made available by the Chief Pharmaceutical Inspector.
GIF emphasized that taking the defective medicine carries a serious threat to the health and life of those taking the preparation. It is impossible to determine the correct way to dose the product.
