Phenhydan Injection: DHPC on Visual Particles, Filter Required
Summary
BfArM published an updated DHPC from Desitin Arzneimittel GmbH regarding Phenhydan solution for injection (phenytoin sodium), following particle contamination identified in batch 021950 during official sample analysis. The company clarified that a syringe filter with 0.2-0.45 µm pore size must be used when drawing up the solution, then removed before patient administration. This supersedes the November 2025 filter guidance which was corrected for accuracy.
What changed
BfArM updated its DHPC on Phenhydan solution for injection following identification of a visible particle in batch 021950 during official quality testing. Desitin Arzneimittel GmbH clarified the filtration procedure: a 0.2-0.45 µm syringe filter is mandatory during preparation, but must be removed prior to IV administration. This March 2026 update corrects prior November 2025 filter guidance.\n\nHealthcare providers administering Phenhydan injection must verify batch numbers and implement the particle filtration step into their preparation protocols. Injectable solutions with visible particulates pose serious risks of embolism, inflammation, or organ damage if administered unfiltered. Pharmacies and clinical wards should update standard operating procedures and ensure appropriate filter stock is available for this specific batch.
What to do next
- Use 0.2-0.45 µm syringe filter when drawing up Phenhydan injection solution from batch 021950
- Remove filter after drawing up solution and before patient administration
- Report any adverse events associated with particles to pharmacovigilance
Archived snapshot
Apr 12, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Update of Direct Healthcare Professional Communication (DHPC) on Phenhydan solution for injection: risk of visual particles, use of a particle filter
2026.03.19
Active substance: Phenytoin sodium
2026.03.19:
The company Desitin Arzneimittel GmbH provides additional information on the correct procedure for filtration. A syringe filter (pore size 0.2 µm – 0.45 µm) must be used when drawing up the Phenhydan injection solution. After drawing up the solution and before administration, the filter must be removed.
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, DownloadVeroeffentlichtAmEN
2026.03.19
PDF, 183KB, File does not meet accessibility standards
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