In coordination with the State Office for Health and Social Affairs Berlin (LAGeSo), Esteve Pharmaceuticals GmbH has reported regarding the presence of particles in some of the vials after product reconstitution. Which has made them take precautionary measures in order to ensure the safety of patients.

ISOZID is indicated for intravenous treatment of tuberculosis in patients unable to take oral therapy or with absorption disorders, with a switch to oral administration recommended as soon as feasible. During stability studies, visible particles were detected in batch 286480A, leading to its recall from wholesalers and pharmacies. To maintain supply, batch 286490A was released on the postulation it was unaffected.

Following testing of batch 286490A, however, recognized visible particles in some vials. Although no adverse reactions or reduced efficacy have been reported to date, a potential risk to patients cannot be omitted. Given the absence of alternative intravenous isoniazid products on the German market and to prevent shortages, Esteve Pharmaceuticals GmbH, in agreement with BfArM and LAGeSo, has decided not to recall this batch but to allow its continued use under the specified precautions.

Healthcare professionals are kindly asked to stay vigilant, inspect solution before administration & report any suspected adverse reactions, a DHPC was published on 10.09.2025.

Learn more and find the DHPC: Direct Healthcare Professional Communication (DHPC) on Isozid 0.5 N powder for solution for infusion: visual particles, use of a particle filter