Changeflow GovPing Drug Safety Yttrium Citrate (90Y)-YMM-1 Failed Sterility Test
Urgent Notice Removed Final

Yttrium Citrate (90Y)-YMM-1 Failed Sterility Test

Favicon for www.swissmedic.ch Swissmedic Health Professional Communications
Published March 12th, 2026
Detected March 12th, 2026
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Summary

Swissmedic has issued a communication regarding Citrate d'Yttrium (90Y)-YMM-1, Suspension for Injection, batch Z008. The batch failed its sterility test after incubation. While no immediate patient danger is expected, affected patients require close monitoring.

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What changed

Swissmedic has issued a Health Professional Communication (DHPC) concerning Citrate d'Yttrium (90Y)-YMM-1, Suspension for Injection, specifically batch Z008. The batch failed its sterility test after 7 days of incubation, indicating a potential quality issue. The manufacturer is b.e.imaging AG.

While an immediate risk to patients is not anticipated, healthcare providers are instructed to closely monitor patients who have received injections from this batch for any adverse drug reactions. Further details are available in the company's information letter. This notice implies that the affected batch should not be used and may need to be recalled or quarantined.

What to do next

  1. Review batch Z008 of Citrate d'Yttrium (90Y)-YMM-1 for potential recall or quarantine.
  2. Monitor patients who received injections from batch Z008 for adverse drug reactions.
  3. Consult the company's information letter for further guidance.

Source document (simplified)

Context sidebar

DHPC – Citrate d'Yttrium (90Y)-YMM-1 (yttrii(90-Y) citras)

Nicht konforme Sterilitätsprüfung nach Freigabe

12.03.2026

| Präparat | Citrate d'Yttrium (90Y)-YMM-1, Suspension zur Injektion |
| --- | --- |
| Zulassungsnummer | 51703 |
| Wirkstoff | yttrii(90-Y) citras |
| Zulassungsinhaberin | b.e.imaging AG |
| Betroffene Charge | Z008 |

Die Sterilitätsprüfung an einem Muster der betroffenen Charge schlug nach 7 Tagen Inkubation bei 30–35 °C auf einem Kulturmedium (Thioglycolat) fehl. Eine unmittelbare Gefährdung der Patienten ist nach aktuellem Kenntnisstand nicht zu erwarten. Patienten, denen bereits eine Injektion aus dieser Charge verabreicht wurde, müssen engmaschig auf Anzeichen einer unerwünschte Arzneimittelwirkungen überwacht werden.

Weitere Informationen entnehmen Sie bitte dem Informationsschreiben der Firma.


- Company information letter
DHPC – Citrate d'Yttrium (90Y)-YMM-1 (yttrii(90-Y) citras) (PDF, 512 kB, 12.03.2026)

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Source

Favicon for www.swissmedic.ch
Swissmedic Health Professional Communications swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/health-professional-communication--hpc-.html
Drug Safety
Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
Various
Published
March 12th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Drug manufacturers Healthcare providers Pharmaceutical companies
Geographic scope
Switzerland

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Market Surveillance Product Quality

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