The Ministry of Health, through the Spanish Agency of Medicines and Medical Devices (AEMPS), has issued an order to withdraw from the market a well-known antibiotic medication used to treat pharyngitis and other infections. The withdrawal affects all distributed units of a specific batch of Benzetacil 2,400,000 IU, presented in powder and solvent format for injectable suspension. This medication, indicated for infections caused by susceptible germs such as pharyngitis, tonsillitis, and syphilis, has been identified as part of batch T008 with an expiration date of 31/12/2026, in which the units have been mistakenly packaged in a box labeled as Benzetacil 1,200,000 IU, although the inner vial contains the correct dosage according to the labeling.
The AEMPS has classified this incident as a class 2 quality defect, which means it does not pose a life-threatening risk to patients. However, the withdrawal of all units from the affected batch and their return to the corresponding laboratory has been ordered.
The medication Benzetacil 2,400,000 IU is mainly used in the treatment of syphilis, where high doses of benzathine benzylpenicillin are required. The medication leaflet indicates that it contains sodium, specifically 43.78 mg per vial, equivalent to 2% of the WHO-recommended maximum daily intake of sodium for adults. It also includes 20.15 mg of soybean lecithin per vial, so it is advised not to be used by individuals allergic to peanuts or soy.
In view of this situation, health authorities recommend that the autonomous communities monitor the withdrawal of this medication. Those who have purchased the product should refrain from consuming it and proceed with its return to the place of purchase for replacement and removal of the defective batch.
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Clément Destoumieux
PRESENT: + 20 years in complex legal and IT projects in France, the UK and Spain Expert in BioExpert exclusive network of experts in the sectors of life science and investment. Startups coordinator of ANIS (Spanish Association of Health Journalists) Lider ehealth in Asociación Española de Start up Active member of ASEBIO (Leading Spanish Biotech Association) PAST: Sociedad Española Informática de la Salud MBA in Ecole Des Mines – Nantes Master Degree in Ipag Business School in Paris