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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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Okay your article says ” Buccolam products”, I carry Buccolam Madazolam which is the adult version, with me at all times. Best ring my chemist.
Thanks for sharing…
Hi Ann,
I’ve just updated the story so that the specific products are listed. Also, you’ll note that the HPRA has said this is more of a matter for pharmacists and patients don’t need to take any action. We don’t want to unnecessarily worry any of you :)
In fairness, Michelle, there was no need to report it at all.
While not very common, there are a few instances every year when products are recalled from pharmacies.
It always causes unnecessary worry for patients when it is reported.
IF there is a recall that DOES need to go to public level (thankfully rare) media outlets are notified.
Ah Ross, leave it out.
Exactly. And product recall is actually a sign that quality control is happening, AND working.
Its not the ‘adult’ version. My son has it since 6.@ David Andrews. Don’t be so rude. This medication means the difference between life and death so please control yourself and have some consideration.
Cannabis is excellent for children who suffer seizures, not smoking it of course but extracted cbd in cannabis
The worst pharma screw up was Bayer who gave HIV infected blood to haemophiliacs in the states back in the 1990′s.
After the discovery was made instead of destroying the blood they shipped it to Europe and Japan where more people received the blood.
Some of the executives in Japan were jailed, I’m assuming the blood was finally destroyed.
Glen, that was in the 80′s…
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