Drugs used to treat seizures in children recalled

The Health Products Regulatory Authority recalls batches of Buccolam Oromucosal Solution

The Health Products Regulatory Authority (HPRA), formerly the Irish Medicines Board, advised that ViroPharma SPRL recall several batches of the Buccolam Oromucosal Solution products from pharmacies.

The Health Products Regulatory Authority (HPRA), formerly the Irish Medicines Board, advised that ViroPharma SPRL recall several batches of the Buccolam Oromucosal Solution products from pharmacies.

Thu, Jul 31, 2014, 00:48

Several batches of a drug used to treat convulsive seizures in children and adolescents have been recalled from pharmacies as a precautionary measure.

The Health Products Regulatory Authority (HPRA), formerly the Irish Medicines Board, advised that ViroPharma SPRL recall several batches of the Buccolam Oromucosal Solution products from pharmacies.

The products being recalled are Buccolam 2.5mg Oromucosal Solution,Buccolam 5mg Oromucosal Solution, Buccolam 7.5mg Oromucosal Solution and Buccolam 10mg Oromucosal Solution.

Buccolam is used to stop prolonged, acute convulsive seizures in children and adolescents and can only be obtained with a prescription.

Dr Kevin O’Donnell, Market Compliance Manager at the authority, said the recall was precautionary in nature.

“No safety or quality issues have been identified in any of the batches released onto the market. 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.”

Pharmacists are advised to quarantine any units of the Buccolam batches being recalled and to return them to their wholesaler, from whom replacement batches can be obtained. All replacement batches were manufactured at a different production site.