THE IRISH HEALTH Products Regulatory Authority (HPRA) has today confirmed that an epilepsy drug is being recalled “as a precautionary measure”.
The company ViroPharma SPRL is recalling several specific batches of Buccolam Oromucosal Solution, which is used to treat convulsive seizures in children and adolescents.
There was an issue identified in relation to manufacturing controls at one site and there was a “theoretical risk of cross-contamination”, the HPRA said in a statement today.
There is no evidence of any actual cross-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.
The specific products being recalled are:
As a precautionary measure, pharmacists are being advised to quarantine any units of the Buccolam batches being recalled and to return them to their wholesaler. Replacement batches – manufactured at a different site – will be provided.
“No safety or quality issues have been identified in any of the batches released onto the market,” commented Kevin O’Donnell, Market Compliance Manager at the HPRA. “The recall only applies to packs at pharmacy level, and the risk presented by this issue is considered to be very low. Patients do not have to return packs to their pharmacy and can continue taking their medicine.”
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