Curosurf 240 mg/3 ml Suspension Recall by Chiesi SAS
Summary
The French ANSM has announced a recall of a specific lot (Lot 1211845, Exp 07/2026) of Curosurf 240 mg/3 ml suspension for endotracheobronchial instillation. This action was initiated by the manufacturer, Chiesi SAS, as a precautionary measure due to a resolved deviation observed during environmental monitoring.
What changed
The French National Agency for Medicines and Health Products Safety (ANSM) has reported a precautionary recall of Lot 1211845 (expiring 07/2026) of Curosurf 240 mg/3 ml suspension for endotracheobronchial instillation, manufactured by Chiesi SAS. This recall is a direct measure taken with the ANSM following a resolved deviation identified in the production site's environmental monitoring. While no pharmacovigilance cases related to this quality defect have been reported, the recall is being conducted directly with the affected hospital facilities.
Healthcare providers in France who may have received or administered this specific lot of Curosurf should be aware of the recall and follow the instructions provided by Chiesi SAS and the ANSM. Although the deviation is resolved and no adverse events have been reported, entities should ensure proper handling and return of the affected product. No specific compliance deadline or penalty information is provided, as this is a direct recall to healthcare facilities.
What to do next
- Verify if Lot 1211845 of Curosurf 240 mg/3 ml suspension has been received.
- Segregate and return affected product according to manufacturer and ANSM instructions.
- Review internal procedures for handling product recalls and deviations.
Source document (simplified)
Rappel de lot effectué en direct auprès des établissements hospitaliers concernés Le Laboratoire Chiesi SAS procède, en accord avec l’ANSM et par mesure de précaution, au rappel du lot mentionné ci-dessous de la spécialité
- Curosurf 240 mg/3 ml, suspension pour instillation endotrachéobronchique - boîte de 1 flacon (CIP 34009 557 753 7 9)
Lot 1211845 (Exp 07/2026)
Ce rappel fait suite à une déviation désormais résolue, observée lors de la revue du suivi environnemental du site de production de la spécialité.
Le laboratoire précise qu'aucun cas de pharmacovigilance, en lien avec le défaut qualité, n'a été rapporté à ce jour.
Ce rappel de lot est effectué en direct auprès des établissements hospitaliers concernés.
Aucun numéro d'alerte n'a été attribué.
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