Active Substance:
Midazolam Hydrochloride
Background Information:
The Health Products Regulatory Authority (the HPRA, formerly the Irish Medicines Board) advises that, as a precautionary measure, the company ViroPharma SPRL is recalling from pharmacies several specific batches of the Buccolam Oromucosal Solution products used to treat convulsive seizures in children and adolescents.
The reason for the recall is that an issue has been identified in relation to manufacturing controls in place at the manufacturing site. As a consequence, there was a theoretical risk of contamination at the manufacturing site. This risk has been assessed as being very low. There is no evidence of any actual contamination having occurred with the Buccolam products, and the potential contaminant has not been detected in any batch of Buccolam during product testing to date. Nevertheless, these batches of Buccolam are being recalled to pharmacy level as a precautionary measure.
Recall letters were issued by ViroPharma SPRL, to wholesalers and hospital and community pharmacists on Tuesday, July 29th 2014. Pharmacists and wholesalers are being asked to return units from the above-listed batches, for replacement. The replacement batches were manufactured at a different manufacturing site and they are immediately available.
Advice to Patients and Healthcare Professionals:
Information for Patients / Carers: No action is required of patients. Patients are advised to continue taking their medicine. There is no need to return any packs to your pharmacy.
No safety or quality issues have been identified in respect of this matter. This recall is being carried out purely as a precautionary measure.
Specific Information for Pharmacists:
All pharmacies registered in Ireland have been sent a recall letter via post (mailed 29 July, 2014), which provides information on the issue and which details the steps to be taken. The recall letter is available below.
There is no need to contact patients. If patients contact you, please provide them with the information for patients /carers above.
Download Buccolam Pharmacy Recall Letter (pdf)
Specific Information for Other Healthcare Professionals: No action is required of other Healthcare Professionals at this time. This recall only applies to supplies at pharmacy level. Patients should continue taking their medicine.
No safety or quality issues have been identified in respect of this matter. This recall is being carried out purely as a precautionary measure.
If patients contact you, please provide them with the information for patients /carers above.