The Chief Pharmaceutical Inspector has withdrawn a series of the drug called Eptifab from circulation throughout the country. The reason for the decision is incorrect information contained in the leaflet.
The Chief Pharmaceutical Inspector (GIF) has withdrawn from sale throughout the country a drug called Eptifab, 2mg/mlsolution for injection, batch number LFH0032expiry date 11.2024.
The entity responsible for the drug is Abbott Healthcare Private Limited with its registered office in India. In turn, the entity that obtained consent for the temporary introduction of the medicinal product to the market is the Delfarma company with its registered office in Łódź.
GIF made the decision immediately enforceable.
Reason for decision
In the justification of its decision, GIF stated that the Chief Pharmaceutical Inspector received a request from the Minister of Health to withdraw the medicinal product Eptifab from the market “due to the occurrence of a threat to public health”. This threat resulted from the presentation of an incorrect dosage method in the leaflet.
During the investigation, it was established that the leaflet accompanying the drug Eptifab with the number LFH0032 contains a faithful translation of the content of the original product information accompanying the drug distributed in India, for which the marketing authorisation holder is Abbott Healthcare Private Limited.
It was found that the original package leaflet contained incorrect data, namely the dosing information for patients with normal and reduced renal function was changed.
“In the case at hand, the occurrence of a real threat to the health and potentially also the life of patients is, in the opinion of the authority, obvious. Incorrect dosing of a medicinal product in the form of a solution for injection is – as already indicated above – a situation that may cause direct negative health consequences for patients” – we read in the justification.
Main image source: Shutterstock