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

Pfizer Limited has informed us that the packs for the affected batches below 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.

From:
Medicines and Healthcare products Regulatory Agency
Published
23 July 2020
Message type:
Medicines recall/notification
Medical specialty:
Pharmacy
Issued:
23 July 2020

MDR Number

MDR 135-12/19

Company Name

Pfizer Limited

Product description

Ecalta 100mg powder for concentrate for solution for infusion

  • Batch number: DN 6937
    • Expiry date: 30/09/2022
    • Pack size: 1 vial
  • Batch number: DX 1158
    • Expiry date: 30/09/2022
    • Pack size: 1 vial

Active pharmaceutical ingredient: anidulafungin

Section 5 - How to store ECALTA

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

Correct information that should be in the PILs:The reconstituted solution may be stored up to 25oC for up to 24 hours. The infusion solution may be stored at 25oC (room temperature) for 48 hours, (do not freeze) and should be administered at 25oC (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”.

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

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

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.

NHS England and NHS Improvement Regional Offices are asked to forward this alert to community pharmacy contractors.

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

Published 23 July 2020