BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Direct Healthcare Professional Communication (DHPC) on Phenhydan solution for injection: risk of visual particles, use of a particle filter

Active substance: phenytoin sodium

2025.11.07:
Desitin Arzneimittel GmbH corrects the information on the filters to be used.

2025.11.06:
The company Desitin Arzneimittel GmbH informs about a possible quality defect of the medicinal product Phenhydan solution for injection. During an official sample analysis of batch 021950, a particle was identified in one ampoule. For safety reasons, the company therefore recommends the use of a
particle filter (pore size 0.2-0.45 µm) for ampoules of batch 021950.

Download DHPC/Information letter , Download_VeroeffentlichtAm_EN PDF, 185KB, File does not meet accessibility standards