Recall of certain batches of Buccolam Oromucosal Solution - Important information for patients and healthcare professionals

Notice type: Recall

Date: 29/08/2018


Background Information Or Related Documents:
Buccolam Recall August 2018

The HPRA wishes to advise that the above listed  batches of Buccolam Oromucosal Solution are being recalled to pharmacy level with immediate effect. The reason for the recall and details on how the recall is being carried out are stated in the recall letter that has been issued to pharmacists today (August 29th 2018). This letter can be accessed here.

While packs are not being recalled from patients, the carers of patients using Buccolam may be contacted by their pharmacist today or in the coming days to ensure that they have a copy of a Dear Caregiver letter (available here) which relates to this issue.  It is important that carers ensure that they read this letter and that they place a colour copy of it next to the medicine, at wherever location the medicine may be stored - in the patient’s home, in their school, at a relative’s home (if the medicine is stored there). Further information about the dissemination of this here is available in the recall letter. 

Replacement batches are available to order.  

The HPRA continues to oversee the manufacturer’s actions that have been taken in response to this issue and to prevent a recurrence of it. 

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