Biotrakson is an antibiotic that is given by injection – either into a vein or into a muscle. It is used in the case of bacterial infections. By the decision of the Main Pharmaceutical Inseptorate, two series of this product can now be returned to pharmacies. The reason is “reasonable suspicion of a quality defect”.
The Main Pharmaceutical Inspectorate informed about the possibility of returning to pharmacies two series of Biotrakson medicinal product – an antibiotic administered intravenously or intramuscularly.
It is about Biotrakson (Ceftriaxonum), powder for solution for injection or infusion 2 g, with batch number 25020921A and expiry date 09.2023 and batch number 25030921A and deadline 09.2023.
The entity responsible is Zakłady Farmaceutyczne POLPHARMA SA, ul. Pelplińska 19, 83-200 Starogard Gdańsk.
The reason for the GIF decision is a justified suspicion of a qualitative defect consisting in the product obtaining an out-of-specification result in the endotoxin parameter in archival samples, which may result in a serious threat to the health or life of the patient.
The GIF announcement on the notification of the possibility of returning a medicinal product to a pharmacy was published on Wednesday in the official journal of the minister of health. (PAP)
Author: Katarzyna Lechowicz-Dyl
ktl/ mir/
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