Class 4 Medicines Defect Information: Pfizer Limited, Ecalta (anidulafungin) 100mg powder for concentrate for solution for infusion, EL (20)A/32

Packs from the two listed batches have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion solution, which now state that it must not be frozen (section 5).

SPS commentary:

When dispensing medicine from the affected batches, it should be ensured that the correct PIL (available via the electronic medicines compendium) is issued.


Medicines and Healthcare products Regulatory Agency