The Medicines and Health products Regulatory Agency (MHRA) has issued a class four medicines defect information notice for Ecalta 100mg powder for concentrate solution for infusion.
The product manufacturer, Pfizer, has informed MHRA that the packs for the 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 five.
How to store ECALTA or Section Five
| 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”. |
Product details
Ecalta 100mg powder for concentrate for solution for infusion.
| Batch Number | Expiry Date | Pack Size |
| DN 6937 | 30/09/2022 | 1 vial |
| DX 1158 | 30/09/2020 | 1 vial |
Community pharmacists have been adviced to ensure that the correct PIL is issued while dispensing the medicine from the affected batches listed.
The correct PIL is available from the electronic medicines compendium (EMC) website.
