Class 4 Medicines defect information: Ecalta 100mg powder for concentrate for solution for infusion (Pfizer Limited)

Class 4 Medicines defect information: Ecalta 100mg powder for concentrate for solution for infusion (Pfizer Limited)

July 23, 2020

Class 4 Medicines defect information: Ecalta 100mg powder for concentrate for solution for infusion (Pfizer Limited)

Drug alert number: EL (20)A/32

Date issued: 23 July 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Class 4 Medicines defect information: Ecalta 100mg powder for concentrate for solution for infusion (Pfizer Limited) 

Pfizer Limited has informed MHRA that the packs for the above batches have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion solution in section 5.

Section 5 How to store ECALTA

Incorrect information in the PILs of the affected batches Correct information that should be in the PILs
The reconstituted solution may be stored up to 25C for up to 24 hours. The infusion solution may be stored at 25C (room temperature) for 48 hours or stored frozen for at least 72 hours and should be administered at 25C (room temperature) within 48 hours.

The reconstituted solution may be stored up to 25C for up to 24 hours. The infusion solution may be stored at 25C (room temperature) for 48 hours, (do not freeze) and should be administered at 25C (room temperature) within 48 hours.

The section of the PIL for medical or healthcare professionals was also updated to include the following statement:

“The infusion solution must not be frozen”.

Ecalta 100mg powder for concentrate for solution for infusion (Pfizer Limited)  EU/1/07/416/002

Batch Number Expiry Date Pack Size 
DN 6937 30/09/2022 1 vial
DX 1158 30/09/2020 1 vial

Advice for healthcare professionals

When dispensing this medicine from the affected batches listed above, please ensure that the correct PIL is issued.

The correct PIL is available from the electronic medicines compendium (EMC) website by clicking on the link below:

PIL for ECALTA 100mg powder for concentrate for solution for infusion

The Summary of Product Characteristics (SmPC Section 6.3) has been updated to state “The infusion solution may be stored at 25ºC for 48 hours. Do not freeze”.

The updated SmPC is available on the EMC website: www.medicines.org.uk

View full alert here

Further Information

For suspected adverse reaction and/or medical information queries, please contact:

Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS

Telephone: 01304 616 161




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