To the attention of interested persons
Press release of the National Agency for Medicines and Medical Devices on the recall of the batches of FERVEX – Granules for oral suspension (adults) and FERVEX – Granules for oral suspension (children)
The decision for recall of FERVEX for Adults – Granules for oral solution and FERVEX for Children – Granules for oral solution has been taken following the information received from the NAMMD via rapid alert system (from the French competent authority) and from the manufacturer (Bristol-Myers Squibb).
The decision concerning marketing recall has been taken due to the detection during routine control, performed by the French manufacturer, of microbial contamination of Fervex “Raspberry”. This product is not marketed in Romania.
Since the contamination source is an excipient used in Fervex formulations (saccharose), the company decided the recall of all batches of Fervex for Adults and Fervex for Children, granules for oral solution, manufactured with this excipient, as a precautionary measure. This recall is performed in all the states where these products are manufactured, including other EU member states.
Potential adverse reactions in case of ingesting the potentially contaminated product are not serious, e.g. abdominal pain, fever, vomiting, diarrhoea.
To this date, such adverse reactions have not been signalled via the Pharmacovigilance system.